A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma

An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790503

Enrollment

Registered

2013-02-13

Start date

2013-07-18

Completion date

2020-03-04

Last updated

2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Newly Diagnosed Glioblastoma

Keywords

glioblastoma, GBM

Brief summary

The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).

Detailed description

Study drug will be administered twice daily for 7 days prior to the initiation of RT (radiation therapy)and will continue twice daily during the course of RT. The RT schedule will be once daily for 5 days per week for 6 weeks (total radiation dose of 60 Gy. Oral temozolomide will be administered once daily (7 days per week) for the duration of RT. Four weeks after the completion of the course of RT, patients will be started on once-daily adjuvant temozolomide (Day 1-5 of a 28 day cycle) and PLX3397 twice daily (28 days of a 28 day cycle) for up to 12 cycles in the absence of progressive disease or unacceptable toxicities. After discontinuation of study drug, patients will continue to be followed for OS every 6 months. For patients participating in the run-in Phase 1b of the study, intra patient dose escalation will be permitted after a RP2D has been established. The Phase 2 portion of the study will enroll patients to be treated with PLX3397 at RP2D. For the Phase 1b portion of the study, 2 cohorts (800 mg/day and 1000 mg/day) are planned to be enrolled at approximately 7-10 sites. Each cohort will consist of approximately 7 patients. Therefore, a minimum of 14 patients are planned to be enrolled in Phase 1b. Additional patients may be required for replacement patients, or if lower dose cohorts (600 mg or 400 mg) are required. For the Phase 2 portion of the study, enrollment is planned to include approximately 44 patients.

Interventions

DRUGPLX3397

RADIATIONRadiation Therapy

DRUGTemozolomide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female patients ≥18 years old. * Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides. * The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration. * A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1. * Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality. * Patients must receive RT at the participating institution. * Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose. * Karnofsky performance status of ≥70. * Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb \>10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN). * Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

Exclusion criteria

* Evidence of recurrent GBM or metastases detected outside of the cranial vault. * Investigational drug use within 28 days of the first dose of PLX3397 or concurrently. * Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment. * Prior radiation or chemotherapy for glioblastoma or glioma. * Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields. * Prior allergic reaction to temozolomide. * History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage. * Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix. * Chronic active hepatitis B or C. * Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug. * Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results. * Women of child-bearing potential who are pregnant or breast feeding. * At Screening QTcF ≥450 msec for males and ≥470 msec for females.

Design outcomes

Primary

Measure	Time frame	Description
Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group	Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.	Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.
Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature	Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.	mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.

Secondary

Measure	Time frame	Description
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.	Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT). The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.
Summary of the Overall Survival in The Study Population	Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 months	Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.
Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature	Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.	Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Baseline up to 30 days after last dose, up to 4 years 4 months	—
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Assessed from Baseline and every 8 weeks, up to 4 years 4 months	Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), \>=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, \>25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Baseline up to 30 days after last dose, up to 4 years 4 months	—
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Baseline up to 30 days after last dose, up to 4 years 4 months	—
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.	Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT). The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Baseline up to 30 days after last dose, up to 4 years 4 months	—

Countries

United States

Participant flow

Recruitment details

A total of 65 participants (22 in Phase 1b; 43 in Phase 2) who met all inclusion criteria and no exclusion criteria were enrolled and treated in the study at 10 clinic sites in the United States.

Pre-assignment details

This study included Phase 1b dose escalation where 5 cohorts were planned to be enrolled, each with approximately 7 participants (3+3 design) and Phase 2 where 37 participants were planned to be enrolled with the 7 participants treated at the RP2D level determined in the Phase 1b dose escalation phase yielding approximately 44 participants.

Participants by arm

Arm	Count
Phase 1b Dose Escalation - 600 mg/600 mg Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	3
Phase 1b Dose Escalation - 600 mg/800 mg Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	1
Phase 1b Dose Escalation - 600 mg/1000 mg Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks), followed by 1000 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	1
Phase 1b Dose Escalation - 600 mg Participants received 600 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks). No adjuvant therapy thereafter	2
Phase 1b Dose Escalation - 800 mg/1000 mg Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks) followed by 1000 mg PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	5
Phase 1b Dose Escalation - 800 mg (5 Days) Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.	5
Phase 1b Dose Escalation - 800 mg/600 mg Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 600 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	1
Phase 1b Dose Escalation - 800 mg/800 mg Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	1
Phase 1b Dose Escation - 800 mg (7 Days) Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (7 days per week for six weeks) No adjuvant therapy thereafter.	3
Phase 2 - 800 mg/800 mg Participants received 800 mg/day PLX3397 in combination with radiation therapy, and temozolomide (5 days per week for six weeks) followed by 800 mg/day PLX3397 (daily dosing) and temozolomide (once daily on days 1-5 of each 28 day cycle) adjuvant therapy thereafter.	27
Phase 2 - 800 mg Participants received 800 mg/day PLX3397 in combination with radiation therapy and temozolomide (5 days per week for six weeks). No adjuvant therapy thereafter.	16
Total	65

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010
Overall Study	Adverse Event	1	0	0	0	0	2	0	0	2	4	7
Overall Study	Death	0	0	0	0	0	0	0	0	0	1	0
Overall Study	Disease progression	2	1	0	1	2	1	0	1	0	17	7
Overall Study	Non Compliance	0	0	0	0	1	0	0	0	0	0	0
Overall Study	Other	0	0	0	0	1	0	0	0	1	2	0
Overall Study	Physician Decision	0	0	0	0	0	0	0	0	0	1	1
Overall Study	Protocol Violation	0	0	0	0	0	0	0	0	0	1	0
Overall Study	Withdrawal by Subject	0	0	1	1	1	2	1	0	0	0	1

Baseline characteristics

Characteristic	Total	Phase 1b Dose Escalation - 600 mg/800 mg	Phase 1b Dose Escalation - 600 mg/1000 mg	Phase 1b Dose Escalation - 600 mg/600 mg	Phase 1b Dose Escalation - 600 mg	Phase 1b Dose Escalation - 800 mg/1000 mg	Phase 1b Dose Escalation - 800 mg (5 Days)	Phase 1b Dose Escalation - 800 mg/600 mg	Phase 1b Dose Escalation - 800 mg/800 mg	Phase 1b Dose Escation - 800 mg (7 Days)	Phase 2 - 800 mg/800 mg	Phase 2 - 800 mg
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	28 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	20 Participants	5 Participants
Age, Categorical Between 18 and 65 years	37 Participants	1 Participants	0 Participants	3 Participants	2 Participants	5 Participants	4 Participants	0 Participants	1 Participants	3 Participants	7 Participants	11 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 11.9	23.0 years STANDARD_DEVIATION 0	73 years STANDARD_DEVIATION 0	51.3 years STANDARD_DEVIATION 6.4	48.0 years STANDARD_DEVIATION 17	50.8 years STANDARD_DEVIATION 15.7	60.8 years STANDARD_DEVIATION 8.6	30.0 years STANDARD_DEVIATION 0	51.0 years STANDARD_DEVIATION 0	53.3 years STANDARD_DEVIATION 4.2	55.7 years STANDARD_DEVIATION 10.8	59.0 years STANDARD_DEVIATION 10.7
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	58 Participants	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants	4 Participants	1 Participants	1 Participants	3 Participants	25 Participants	16 Participants
Region of Enrollment United States	65 participants	1 participants	1 participants	3 participants	2 participants	5 participants	5 participants	1 participants	1 participants	3 participants	27 participants	16 participants
Sex: Female, Male Female	24 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	3 Participants	1 Participants	0 Participants	0 Participants	8 Participants	7 Participants
Sex: Female, Male Male	41 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants	1 Participants	3 Participants	19 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 1	0 / 1	0 / 2	0 / 5	0 / 5	0 / 1	0 / 1	0 / 3	1 / 27	0 / 16
other Total, other adverse events	1 / 3	1 / 1	1 / 1	2 / 2	5 / 5	5 / 5	0 / 1	1 / 1	3 / 3	18 / 27	13 / 16
serious Total, serious adverse events	1 / 3	0 / 1	0 / 1	2 / 2	2 / 5	2 / 5	0 / 1	0 / 1	3 / 3	13 / 27	9 / 16

Outcome results

Primary

Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group

Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.

Time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.

Population: mPFS was assessed in the modified intent-to-treat RP2D and the per protocol (PP) populations.

Arm	Measure	Group	Value (MEDIAN)
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group	mITT RP2D	6.7 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group	PP RP2D	6.9 months

Primary

Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature

mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.

Time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.

Population: mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.

Arm	Measure	Value (MEDIAN)
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature	7.7 months
RP2D-0525 (Cycle 1, Day 1)	Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature	7.6 months
RP2D-0825	Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature	7.0 months
RP2D-0525 (Rest Period, Day 15)	Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature	6.1 months

p-value: 0.45695% CI: [0.71, 1.36]Log Rank

p-value: 0.61995% CI: [0.77, 1.43]Log Rank

p-value: 0.27295% CI: [0.65, 1.26]Log Rank

Secondary

Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population

Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months

Population: Abnormal chemistry and hematology values were assessed in the mITT population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	1 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	2 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	1 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	1 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	1 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
Phase 1b Dose Escalation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Bone marrow failure	1 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphopenia	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutrophil count decreased	2 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Anaemia	1 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Febrile neutropenia	1 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Lymphocyte count decreased	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Leukopenia	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	White blood cell decreased	1 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	AST increased	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Haemolysis	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	ALT increased	0 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Platelet count decreased	1 Participants
Phase 1b Dose Escation - 800 mg	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population	Neutropenia	1 Participants

Secondary

Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population

Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months

Population: Abnormal chemistry and hematology values were assessed in the mITT population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Liver function test abnormal	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphocyte count decreased	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	ALT increased	2 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	DRESS	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood alkaline phosphatase increased	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutropenia	6 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood creatinine increased	2 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Thrombocytopenia	3 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood bilirubin increased	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	AST increased	2 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Platelet count decreased	4 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Haemolysis	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphopenia	2 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood iron decreased	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	White blood cell count decreased	4 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Anaemia	5 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutrophil count decreased	2 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Leukopenia	1 Participants
Combined 800 mg, 5 Days/Week	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Febrile neutropenia	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Liver function test abnormal	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Febrile neutropenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood bilirubin increased	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	DRESS	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Platelet count decreased	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphocyte count decreased	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutropenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood iron decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Leukopenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood alkaline phosphatase increased	3 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphopenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood creatinine increased	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutrophil count decreased	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	ALT increased	5 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Anaemia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	White blood cell count decreased	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	AST increased	4 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Thrombocytopenia	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Haemolysis	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood alkaline phosphatase increased	3 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutropenia	7 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Thrombocytopenia	4 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Anaemia	6 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	ALT increased	7 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	AST increased	6 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Platelet count decreased	5 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphopenia	3 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	White blood cell count decreased	5 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutrophil count decreased	2 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Leukopenia	2 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Febrile neutropenia	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphocyte count decreased	2 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood creatinine increased	3 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	DRESS	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Liver function test abnormal	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Haemolysis	0 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood bilirubin increased	1 Participants
RP2D-0825	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood iron decreased	1 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Leukopenia	2 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutrophil count decreased	2 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood bilirubin increased	1 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Liver function test abnormal	1 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	White blood cell count decreased	5 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphopenia	4 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Thrombocytopenia	6 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Bone marrow failure	0 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Platelet count decreased	7 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	AST increased	8 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Neutropenia	9 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Haemolysis	1 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	ALT increased	8 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood alkaline phosphatase increased	3 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Anaemia	7 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood creatinine increased	3 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Lymphocyte count decreased	3 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Febrile neutropenia	2 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	Blood iron decreased	1 Participants
RP2D-0525 (Rest Period, Day 15)	Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population	DRESS	1 Participants

Secondary

Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population

Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months

Population: Safety was assessed in the mITT population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	2 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	3 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	3 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	3 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	3 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	2 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	2 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	2 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	2 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	4 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	2 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	5 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	5 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	5 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	2 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	5 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	1 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	4 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	5 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	2 Participants
Phase 1b Dose Escalation - 800 mg/1000 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	0 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	3 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	2 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	2 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	4 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	4 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	2 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	5 Participants
Phase 1b Dose Escalation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	1 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	1 Participants
Phase 1b Dose Escalation - 800 mg/600 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	1 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	0 Participants
Phase 1b Dose Escalation - 800 mg/800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Eye Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	2 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Cardiac Disorders	0 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	2 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Nervous System Disorders	2 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Psychiatric Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Vascular Disorders	2 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	General Disorders and Administrative Site	3 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Investigations	3 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Ear and Labyrinth	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Blood and Lymphatic Tissue Disorders	1 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	2 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	0 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Infections and Infestations	3 Participants
Phase 1b Dose Escation - 800 mg	Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population	Endocrine Disorders	1 Participants

Secondary

Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population

Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months

Population: Safety was assessed in the mITT population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Psychiatric Disorders	17 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	21 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	General Disorders and Administration Site	24 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	7 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Investigations	12 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	0 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Endocrine Disorders	5 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	2 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	13 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Cardiac Disorders	5 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Immune System Disorders	1 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	7 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Blood and Lymphatic System Disorders	14 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	16 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Nervous System Disorders	22 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Ear and Labyrinth Disorders	3 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	10 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Vascular Disorders	9 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	24 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	2 Participants
Combined 800 mg, 5 Days/Week	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Eye Disorders	7 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Investigations	9 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Endocrine Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Vascular Disorders	4 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	3 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Cardiac Disorders	2 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	2 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	12 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	8 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Psychiatric Disorders	6 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	12 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	0 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Eye Disorders	6 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	General Disorders and Administration Site	13 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	7 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Ear and Labyrinth Disorders	1 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Blood and Lymphatic System Disorders	2 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	6 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Nervous System Disorders	12 Participants
RP2D-0525 (Cycle 1, Day 1)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Immune System Disorders	0 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Endocrine Disorders	6 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	General Disorders and Administration Site	37 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	36 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Nervous System Disorders	34 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	33 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	24 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Psychiatric Disorders	23 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Investigations	21 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	20 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Blood and Lymphatic System Disorders	16 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	16 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Eye Disorders	13 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Vascular Disorders	13 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	10 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	9 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Cardiac Disorders	7 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Ear and Labyrinth Disorders	4 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	2 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	2 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	1 Participants
RP2D-0825	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Immune System Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Injury, Poisoning, and Procedural Complications	18 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Endocrine Disorders	7 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Blood and Lymphatic System Disorders	18 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Musculoskeletal and Connective Tissue Disorders	25 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Immune System Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Ear and Labyrinth Disorders	5 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Investigations	27 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Psychiatric Disorders	27 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Hepatobiliary Disorders	1 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Reproductive System and Breast Disorders	3 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Metabolism and Nutrition Disorders	30 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Gastrointestinal Disorders	41 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	General Disorders and Administration Site	47 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Neoplasms Benign, Malignant, and Unspecified	2 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Nervous System Disorders	43 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Renal and Urinary Disorders	13 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Respiratory, Thoracic, and Mediastinal Disorders	16 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Skin and Subcutaneous Tissue Disorders	45 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Cardiac Disorders	8 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Vascular Disorders	18 Participants
RP2D-0525 (Rest Period, Day 15)	Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population	Eye Disorders	16 Participants

Secondary

Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose

Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), \>=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, \>25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.

Time frame: Assessed from Baseline and every 8 weeks, up to 4 years 4 months

Population: Best Overall Response was assessed in the mITT RP2D population.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	Complete response (CR)	2 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	Partial response (PR)	4 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	CR+PR	6 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	Stable disease	18 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	Progressive disease	9 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	Complete response (CR)	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	Partial response (PR)	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	CR+PR	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	Stable disease	6 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	Progressive disease	3 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	Complete response (CR)	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	Partial response (PR)	2 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	CR+PR	3 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	Stable disease	10 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	Progressive disease	5 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Complete resection	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	Complete response (CR)	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	Partial response (PR)	3 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	CR+PR	4 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	Stable disease	13 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	Progressive disease	6 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Partial resection	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	Complete response (CR)	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	Partial response (PR)	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	CR+PR	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	Stable disease	7 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	Progressive disease	8 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	Complete response (CR)	2 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	Partial response (PR)	4 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	CR+PR	6 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	Stable disease	17 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	Progressive disease	4 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	Complete response (CR)	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	Partial response (PR)	3 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	CR+PR	4 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	Stable disease	11 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	Progressive disease	3 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	Unknown	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	Complete response (CR)	1 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	Partial response (PR)	2 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	CR+PR	3 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	Stable disease	12 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	Progressive disease	9 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	Unable to access	0 Participants
Combined 800 mg, 5 Days/Week	Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	Unknown	0 Participants

Comparison: Comparison between age subgroups: 18-64 years vs 65+ yearsp-value: 0.705t-test, 2 sided

Comparison: Comparison between extent of surgery subgroups: complete resection vs partial resectionp-value: >0.999t-test, 2 sided

Comparison: Comparison between baseline KPS subgroups: 70-89 vs 90-100p-value: 0.099t-test, 2 sided

Comparison: Comparison between MGMT status subgroups: methylated vs unmethylatedp-value: 0.348t-test, 2 sided

Secondary

Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose

Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT). The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.

Time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.

Population: mPFS was assessed in the mITT RP2D population.

Arm	Measure	Group	Value (MEDIAN)
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age: 18-64 years	6 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age: 65+ years	10 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Extent of surgery: complete resection	6 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Extent of surgery: partial resection	9 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 70-89	4 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	11 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	10 months
Combined 800 mg, 5 Days/Week	Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: unmethylated	4 months

Comparison: Comparison between age subgroups: 18-64 years vs 65+ yearsp-value: 0.44t-test, 2 sided

Comparison: Comparison between extent of surgery subgroups: complete resection vs partial resectionp-value: 0.699t-test, 2 sided

Comparison: Comparison between baseline KPS subgroups: 70-89 vs 90-100p-value: 0.003t-test, 2 sided

Comparison: Comparison between MGMT status subgroups: methylated vs unmethylatedp-value: 0.201t-test, 2 sided

Secondary

Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose

Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT). The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.

Time frame: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.

Population: OS was assessed in the mITT RP2D population.

Arm	Measure	Group	Value (MEDIAN)
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 18-64 years	14.3 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Age group: 65+ years	11 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Extent of surgery: complete resection	14 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Extent of surgery: partial resection	13 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Basline KPS: 70-89	8 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	Baseline KPS: 90-100	24 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT status: methylated	15 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose	MGMT: unmethylated	12 months

Comparison: Comparison between age subgroups: 18-64 years vs 65+ yearsp-value: 0.063t-test, 2 sided

Comparison: Comparison between extent of surgery subgroups: complete resection vs partial resectionp-value: 0.969t-test, 2 sided

Comparison: Comparison between baseline KPS subgroups: 70-89 vs 90-100p-value: <0.001t-test, 2 sided

Comparison: Comparison between MGMT status subgroups: methylated vs unmethylatedp-value: 0.501t-test, 2 sided

Secondary

Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature

Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure

Time frame: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.

Population: Median OS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.

Arm	Measure	Value (MEDIAN)
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature	18.8 months
RP2D-0525 (Cycle 1, Day 1)	Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature	20.2 months
RP2D-0825	Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature	17.0 months
RP2D-0525 (Rest Period, Day 15)	Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature	16.9 months

p-value: 0.38995% CI: [0.6, 1.47]Log Rank

p-value: 0.39395% CI: [0.63, 1.42]Log Rank

p-value: 0.46995% CI: [0.63, 1.54]Log Rank

Secondary

Summary of the Overall Survival in The Study Population

Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.

Time frame: Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 months

Population: OS was assessed in the mITT RP2D and PP RP2D populations.

Arm	Measure	Group	Value (MEDIAN)
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival in The Study Population	mITT RP2D	13.1 months
Combined 800 mg, 5 Days/Week	Summary of the Overall Survival in The Study Population	PP RP2D	12.4 months

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026

A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group

Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature

Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population

Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population

Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population

Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population

Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose

Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose

Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose

Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature

Summary of the Overall Survival in The Study Population