A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies

An Open-Label, Dose Escalation, Phase 1 Study of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830869

Enrollment

116

Registered

2009-01-28

Start date

2009-03-02

Completion date

2012-04-20

Last updated

2019-09-09

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

Conditions

Advanced Non-hematologic Malignancies

Keywords

Drug therapy

Brief summary

This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.

Interventions

DRUGIXAZOMIB

All participants will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days. The first stage of the study will be initiated at a starting dose of 0.125 mg/m\^2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Each participant must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or female participants 18 years or older. 2. Eastern Cooperative Oncology Group performance status 0-2. 3. A diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective. In the expanded cohort, enrollment will be limited to participants with a diagnosis of NSCLC, H&N cancer (squamous cell cancer), STS, or PC. 4. Suitable venous access for pharmacokinetic (PK) and pharmacodynamic evaluations. 5. Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse. Male participants who agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse. 6. Voluntary written consent must be obtained. 7. Adequate clinical laboratory values during the screening period. 8. In the escalation portion of the study, radiographically or clinically evaluable tumor was required, but measurable disease as defined by response evaluation criteria in solid tumors (RECIST) criteria was not required. In the MTD disease expansion cohorts and the TPEC, clinically measurable disease as defined by RECIST criteria was required for evaluation of NSCLC, H&N cancer, and STS. Prostate specific antigen (PSA) alone was acceptable for evaluation of PC. 9. For participants in the TPEC, tumor tissue that, in the opinion of the investigator, could have been safely biopsied using a core needle.

Exclusion criteria

Participants meeting any of the following

Design outcomes

Primary

Measure	Time frame	Description
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	Part 1: Cycle 1 Day 1 up to Cycle 1 Day 21	Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count\<500 cells/cubic meter\[cells/mm\^3\])for\>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets \<25,000 cells/mm3)for\>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count\<10,000 cells/mm3; GR 3 peripheral neuropathy;\>=GR 3 nausea/emesis in absence of optimal antiemetic therapy; \>=GR 3 diarrhoea in absence of optimal supportive therapy;GR 3 QTc prolongation noted on average of 3 electrocardiograms (ECGs);\>=GR 3 nonhematological toxicity except GR 3 arthralgia/myalgia or GR 3 fatigue for\<1 week; Delay in initiation of subsequent therapy cycle by\>7 days due to treatment-related toxicity Other\>=GR 2 nonhematological toxicity that opinion of investigator, requires discontinuation of therapy with Ixazomib.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	Part 1: Cycle 1 Day 1 up to Cycle 10 Day 41; Part 2: Cycle 1 Day 1 up to Cycle 12 Day 41	—
Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)	—
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)	Vital sign measurements included diastolic and systolic blood pressure, heart rate, weight and oral temperature.

Secondary

Measure	Time frame	Description
Part 1: E Max: Maximum Observed Effect for Ixazomib	Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose	E max is the maximum inhibition of 20S proteasome activity in whole blood.
Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Part 1: Cycle 1 Days 1 and 11 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose	TEmax is the time to reach the Emax, equal to time (hours) to Emax.
Number of Participants With Best Overall Response	Day 18 up to Day 21 of each cycle (Part 1: up to Cycle 10; Part 2: up to Cycle 12)	Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above normal limits. Progressive disease: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.
Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Part 1: Cycle 1 Days 1 and 11: pre-dose and at multiple time points (up to 72 hours) post-dose	AUC (0-72) is a measure of the area under the plasma concentration-time curve from time 0 to 72 hours post-dose for ixazomib.
20S Proteasome Activity of Ixazomib in the Tumor Tissue	Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose	—
Expression of Biomarker (ATF-3) in Tumor Tissue	Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose	—
Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC	Cycle 1 Days 1 and 4: Predose and (from 4-20 hours) post-dose	The average data of Days 1 and 4 of Cycle 1 was reported.
Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose	C0 is the plasma drug concentration at time zero following bolus intravenous injection.
Part 1: Rac: Accumulation Ratio for Ixazomib	Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose	Rac was estimated as the ratio of AUC (0-72) on Day 11 and AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time 0 to 72 hours post-dose.
Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib	Part 1: Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose	T1/2 is the time required for half of the drug to be eliminated from the plasma.

Countries

Canada, United States

Participant flow

Recruitment details

Participants took part in the study at 7 investigative sites in the United States and Canada from 02 March 2009 to 20 April 2012.

Pre-assignment details

Participants with diagnosis of nonhematologic malignancies were enrolled in 1 of the 2 parts, Part 1: Dose escalation to determine maximum tolerated dose (MTD), and Part 2: Expansion at MTD in 5 expansion cohorts.

Participants by arm

Arm	Count
Part 1: Ixazomib 0.125 mg/m^2 Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	1
Part 1: Ixazomib 0.25 mg/m^2 Ixazomib (MLN9708) 0.25 mg/m\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	1
Part 1: Ixazomib 0.5 mg/m^2 Ixazomib (MLN9708) 0.5 mg/m\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	1
Part 1: Ixazomib 1 mg/m^2 Ixazomib (MLN9708) 1 mg/m\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	7
Part 1: Ixazomib 1.33 mg/m^2 Ixazomib (MLN9708) 1.33 mg/m\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	4
Part 1: Ixazomib 1.76 mg/m^2 Ixazomib (MLN9708) 1.76 mg/m\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	6
Part 1: Ixazomib 2.34 mg/m^2 Ixazomib (MLN9708) 2.34 mg/m\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.	3
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC) Ixazomib (MLN9708) 1.76 mg/m\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.	20
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N) Ixazomib (MLN9708) 1.76 mg/m\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H&N during Part 2 of the study.	22
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC) Ixazomib (MLN9708) 1.76 mg/m\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.	20
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC) Ixazomib (MLN9708) 1.76 mg/m\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.	11
Part 2: Ixazomib 1.76 mg/m^2-TPEC Ixazomib (MLN9708) 1.76 mg/m\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.	20
Total	116

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011
Period 1: Part 1	Adverse Event	0	0	0	0	0	1	1	0	0	0	0	0
Period 1: Part 1	Progressive disease	1	0	1	6	4	4	1	0	0	0	0	0
Period 1: Part 1	Symptomatic deterioration	0	0	0	1	0	1	1	0	0	0	0	0
Period 1: Part 1	Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0	0
Period 2: Part 2	Adverse Event	0	0	0	0	0	0	0	4	3	2	2	0
Period 2: Part 2	Other	0	0	0	0	0	0	0	0	0	1	0	0
Period 2: Part 2	Progressive disease	0	0	0	0	0	0	0	14	11	12	8	15
Period 2: Part 2	Protocol Violation	0	0	0	0	0	0	0	1	0	1	0	0
Period 2: Part 2	Symptomatic Deterioration	0	0	0	0	0	0	0	0	6	3	1	4
Period 2: Part 2	Withdrawal by Subject	0	0	0	0	0	0	0	1	2	1	0	1

Baseline characteristics

Characteristic	Part 1: Ixazomib 0.125 mg/m^2	Part 1: Ixazomib 0.25 mg/m^2	Part 1: Ixazomib 0.5 mg/m^2	Part 1: Ixazomib 1 mg/m^2	Part 1: Ixazomib 1.33 mg/m^2	Part 1: Ixazomib 1.76 mg/m^2	Part 1: Ixazomib 2.34 mg/m^2	Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Part 2: Ixazomib 1.76 mg/m^2-TPEC	Total
Age, Continuous	61.0 years	55.0 years	69.0 years	55.1 years STANDARD_DEVIATION 10.71	59.8 years STANDARD_DEVIATION 14.22	62.3 years STANDARD_DEVIATION 10.98	64.7 years STANDARD_DEVIATION 10.79	58.6 years STANDARD_DEVIATION 11.5	55.1 years STANDARD_DEVIATION 9.99	55.0 years STANDARD_DEVIATION 9.43	63.1 years STANDARD_DEVIATION 5.49	57.6 years STANDARD_DEVIATION 11.24	57.8 years STANDARD_DEVIATION 10.32
Body surface area	1.90 square meter (m^2)	1.80 square meter (m^2)	1.70 square meter (m^2)	1.83 square meter (m^2) STANDARD_DEVIATION 0.298	1.73 square meter (m^2) STANDARD_DEVIATION 0.25	1.82 square meter (m^2) STANDARD_DEVIATION 0.331	2.03 square meter (m^2) STANDARD_DEVIATION 0.153	1.82 square meter (m^2) STANDARD_DEVIATION 0.151	1.82 square meter (m^2) STANDARD_DEVIATION 0.197	1.84 square meter (m^2) STANDARD_DEVIATION 0.276	2.15 square meter (m^2) STANDARD_DEVIATION 0.181	2.08 square meter (m^2) STANDARD_DEVIATION 0.383	1.90 square meter (m^2) STANDARD_DEVIATION 0.282
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	1 Participants	1 Participants	6 Participants	1 Participants	6 Participants	3 Participants	17 Participants	19 Participants	16 Participants	9 Participants	18 Participants	97 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	3 Participants	3 Participants	3 Participants	1 Participants	2 Participants	17 Participants
Height	163.0 centimeter (cm)	173.0 centimeter (cm)	156.0 centimeter (cm)	168.9 centimeter (cm) STANDARD_DEVIATION 8.19	163.3 centimeter (cm) STANDARD_DEVIATION 9.54	167.8 centimeter (cm) STANDARD_DEVIATION 11.44	178.3 centimeter (cm) STANDARD_DEVIATION 5.69	170.0 centimeter (cm) STANDARD_DEVIATION 7.61	173.8 centimeter (cm) STANDARD_DEVIATION 9.11	164.2 centimeter (cm) STANDARD_DEVIATION 11.54	178.3 centimeter (cm) STANDARD_DEVIATION 6.72	171.4 centimeter (cm) STANDARD_DEVIATION 9.23	170.4 centimeter (cm) STANDARD_DEVIATION 9.91
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	6 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants	1 Participants	7 Participants	14 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	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	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) Unknown or Not Reported	0 Participants	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) White	1 Participants	1 Participants	1 Participants	7 Participants	4 Participants	5 Participants	2 Participants	17 Participants	18 Participants	17 Participants	10 Participants	12 Participants	95 Participants
Region of Enrollment Canada	0 participants	0 participants	1 participants	1 participants	0 participants	1 participants	0 participants	4 participants	2 participants	1 participants	0 participants	0 participants	10 participants
Region of Enrollment United States	1 participants	1 participants	0 participants	6 participants	4 participants	5 participants	3 participants	16 participants	20 participants	19 participants	11 participants	20 participants	106 participants
Sex: Female, Male Female	1 Participants	1 Participants	1 Participants	5 Participants	3 Participants	3 Participants	0 Participants	10 Participants	4 Participants	12 Participants	0 Participants	10 Participants	50 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants	10 Participants	18 Participants	8 Participants	11 Participants	10 Participants	66 Participants
Weight	79.70 kilogram (kg)	65.50 kilogram (kg)	64.00 kilogram (kg)	73.37 kilogram (kg) STANDARD_DEVIATION 20.517	66.33 kilogram (kg) STANDARD_DEVIATION 16.589	70.90 kilogram (kg) STANDARD_DEVIATION 21.377	85.47 kilogram (kg) STANDARD_DEVIATION 14.086	70.87 kilogram (kg) STANDARD_DEVIATION 11.16	69.00 kilogram (kg) STANDARD_DEVIATION 12.448	74.06 kilogram (kg) STANDARD_DEVIATION 19.65	94.20 kilogram (kg) STANDARD_DEVIATION 14.321	91.44 kilogram (kg) STANDARD_DEVIATION 30.468	77.17 kilogram (kg) STANDARD_DEVIATION 20.794

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	EG011 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 1	0 / 1	1 / 7	1 / 4	0 / 6	1 / 3	0 / 20	2 / 22	1 / 20	0 / 11	1 / 20
other Total, other adverse events	1 / 1	1 / 1	1 / 1	7 / 7	4 / 4	6 / 6	3 / 3	20 / 20	22 / 22	20 / 20	11 / 11	20 / 20
serious Total, serious adverse events	1 / 1	1 / 1	0 / 1	1 / 7	1 / 4	4 / 6	3 / 3	9 / 20	10 / 22	7 / 20	6 / 11	11 / 20

Outcome results

Primary

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)

Time frame: Part 1: Cycle 1 Day 1 up to Cycle 10 Day 41; Part 2: Cycle 1 Day 1 up to Cycle 12 Day 41

Population: The safety population included all participants who received at least 1 dose of study drug.

Arm	Measure	Group	Value (NUMBER)
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	1 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	1 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	1 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	1 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	1 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	7 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	4 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	1 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	4 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	6 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	3 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	3 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	9 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	20 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	22 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	10 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	19 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	7 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	6 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	11 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	TEAEs	20 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)	SAEs	11 participants

Primary

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Vital sign measurements included diastolic and systolic blood pressure, heart rate, weight and oral temperature.

Time frame: Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)

Population: The safety population included all participants who received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants

Primary

Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities

Time frame: Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)

Population: The safety population included all participants who received at least 1 dose of study drug.

Arm	Measure	Group	Value (NUMBER)
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	1 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	1 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	1 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	2 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	2 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	2 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	2 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	1 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	2 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	1 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	3 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	1 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	1 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	2 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	1 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	1 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	1 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	2 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	8 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	3 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	2 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	1 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	1 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	1 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	2 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	12 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	3 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	3 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	4 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	3 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	2 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	2 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	3 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	6 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	8 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	6 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	2 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	2 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	6 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	2 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Coagulation and bleeding analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytoses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Red blood cell analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Tissue enzyme analyses notelsewhereclassified(NEC)	2 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Protein metabolism disorders NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Marrow depression and hypoplastic anaemias	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Calcium metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Disorders of purine metabolism	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Phosphorus metabolism disorders	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Neutropenias	2 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Thrombocytopenias	14 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Renal function analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Platelet analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukopenias NEC	7 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Leukocytoses NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Potassium imbalance	2 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Anaemias NEC	4 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Sodium imbalance	3 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolism tests NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Metabolic acidoses (excluding diabetic acidoses)	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Liver function analyses	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Mineral and electrolyte analyses	2 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	White blood cell analyses	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Hyperglycaemic conditions NEC	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Magnesium metabolism disorders	1 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities	Urinalysis NEC	1 participants

Primary

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count\<500 cells/cubic meter\[cells/mm\^3\])for\>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets \<25,000 cells/mm3)for\>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count\<10,000 cells/mm3; GR 3 peripheral neuropathy;\>=GR 3 nausea/emesis in absence of optimal antiemetic therapy; \>=GR 3 diarrhoea in absence of optimal supportive therapy;GR 3 QTc prolongation noted on average of 3 electrocardiograms (ECGs);\>=GR 3 nonhematological toxicity except GR 3 arthralgia/myalgia or GR 3 fatigue for\<1 week; Delay in initiation of subsequent therapy cycle by\>7 days due to treatment-related toxicity Other\>=GR 2 nonhematological toxicity that opinion of investigator, requires discontinuation of therapy with Ixazomib.

Time frame: Part 1: Cycle 1 Day 1 up to Cycle 1 Day 21

Population: The DLT population included all participants who received all Cycle 1 doses of ixazomib and who had completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.

Arm	Measure	Value (NUMBER)
Part 1: Ixazomib 0.125 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	0 participants
Part 1: Ixazomib 1 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	1 participants
Part 1: Ixazomib 1.33 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	1 participants
Part 1: Ixazomib 2.34 mg/m^2	Part 1: Number of Participants With Dose Limiting Toxicity (DLT)	3 participants

Secondary

20S Proteasome Activity of Ixazomib in the Tumor Tissue

Time frame: Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose

Population: This outcome measure was not analyzed due to lack of tumor activity data.

Secondary

Expression of Biomarker (ATF-3) in Tumor Tissue

Time frame: Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose

Population: This outcome measure was not analyzed due to lack of tumor activity data.

Secondary

Number of Participants With Best Overall Response

Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above normal limits. Progressive disease: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.

Time frame: Day 18 up to Day 21 of each cycle (Part 1: up to Cycle 10; Part 2: up to Cycle 12)

Population: The response-evaluable population included all participants who received at least 1 cycle of ixazomib treatment, had measurable disease at baseline, and had at least 1 postbaseline response assessment.

Arm	Measure	Group	Value (NUMBER)
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	1 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Best Overall Response	SD	0 participants
Part 1: Ixazomib 0.125 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	0 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Best Overall Response	SD	1 participants
Part 1: Ixazomib 0.25 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Best Overall Response	SD	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	1 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 1: Ixazomib 0.5 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	5 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Best Overall Response	SD	1 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 1 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	3 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 1.33 mg/m^2	Number of Participants With Best Overall Response	SD	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	3 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 1: Ixazomib 1.76 mg/m^2	Number of Participants With Best Overall Response	SD	2 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Best Overall Response	Progressive disease	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Best Overall Response	SD	2 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Best Overall Response	CR	0 participants
Part 1: Ixazomib 2.34 mg/m^2	Number of Participants With Best Overall Response	PR	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Best Overall Response	SD	5 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Best Overall Response	Progressive disease	10 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Best Overall Response	CR	0 participants
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	Number of Participants With Best Overall Response	PR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Best Overall Response	SD	5 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Best Overall Response	PR	1 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Best Overall Response	Progressive disease	8 participants
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	Number of Participants With Best Overall Response	CR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Best Overall Response	Progressive disease	8 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Best Overall Response	CR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Best Overall Response	SD	8 participants
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	Number of Participants With Best Overall Response	PR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Best Overall Response	SD	3 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Best Overall Response	Progressive disease	7 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Best Overall Response	PR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	Number of Participants With Best Overall Response	CR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Best Overall Response	Progressive disease	14 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Best Overall Response	SD	3 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Best Overall Response	CR	0 participants
Part 2: Ixazomib 1.76 mg/m^2-TPEC	Number of Participants With Best Overall Response	PR	0 participants

Secondary

Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib

AUC (0-72) is a measure of the area under the plasma concentration-time curve from time 0 to 72 hours post-dose for ixazomib.

Time frame: Part 1: Cycle 1 Days 1 and 11: pre-dose and at multiple time points (up to 72 hours) post-dose

Population: PK analysis population where data at specified time points was available,defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions, did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Ixazomib 0.25 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 11	60.9 nanogramhour per milliliter (nghr/mL)	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 1	91.6 nanogramhour per milliliter (nghr/mL)	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 11	301.00 nanogramhour per milliliter (nghr/mL)	—
Part 1: Ixazomib 1 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 1	191.87 nanogramhour per milliliter (nghr/mL)	Standard Deviation 40.211
Part 1: Ixazomib 1 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 11	579.91 nanogramhour per milliliter (nghr/mL)	Standard Deviation 246.505
Part 1: Ixazomib 1.33 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 1	391.46 nanogramhour per milliliter (nghr/mL)	Standard Deviation 92.446
Part 1: Ixazomib 1.33 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 11	1161.92 nanogramhour per milliliter (nghr/mL)	Standard Deviation 424.774
Part 1: Ixazomib 1.76 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 1	522.74 nanogramhour per milliliter (nghr/mL)	Standard Deviation 120.122
Part 1: Ixazomib 1.76 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 11	1542.64 nanogramhour per milliliter (nghr/mL)	Standard Deviation 454.015
Part 1: Ixazomib 2.34 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 11	3800.0 nanogramhour per milliliter (nghr/mL)	—
Part 1: Ixazomib 2.34 mg/m^2	Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib	Cycle 1 Day 1	620.0 nanogramhour per milliliter (nghr/mL)	—

Secondary

Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration

C0 is the plasma drug concentration at time zero following bolus intravenous injection.

Time frame: Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

Population: PK analysis population where data at specified time points was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Ixazomib 0.125 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	27.1 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 0.125 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	15.1 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 0.25 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	82.5 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 0.25 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	69.0 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	192.0 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	83.8 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 1 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	272.57 nanogram per mililiter (ng/mL)	Standard Deviation 64.044
Part 1: Ixazomib 1 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	346.70 nanogram per mililiter (ng/mL)	Standard Deviation 170.208
Part 1: Ixazomib 1.33 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	366.16 nanogram per mililiter (ng/mL)	Standard Deviation 146.167
Part 1: Ixazomib 1.33 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	390.08 nanogram per mililiter (ng/mL)	Standard Deviation 209.538
Part 1: Ixazomib 1.76 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	648.97 nanogram per mililiter (ng/mL)	Standard Deviation 597.508
Part 1: Ixazomib 1.76 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	579.54 nanogram per mililiter (ng/mL)	Standard Deviation 210.672
Part 1: Ixazomib 2.34 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 1	901.0 nanogram per mililiter (ng/mL)	—
Part 1: Ixazomib 2.34 mg/m^2	Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration	Cycle 1 Day 11	869.0 nanogram per mililiter (ng/mL)	—

Secondary

Part 1: E Max: Maximum Observed Effect for Ixazomib

E max is the maximum inhibition of 20S proteasome activity in whole blood.

Time frame: Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

Population: PD analysis population where baseline/post-baseline assessments was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive any excluded concomitant medications in Cycle 1,had sufficient effect-time data to permit estimation of PD parameters.

Arm	Measure	Group	Value (MEAN)	Dispersion
Part 1: Ixazomib 0.125 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	4.50 percentage of inhibition	—
Part 1: Ixazomib 0.125 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	7.70 percentage of inhibition	—
Part 1: Ixazomib 0.25 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	10.00 percentage of inhibition	—
Part 1: Ixazomib 0.25 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	17.90 percentage of inhibition	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	46.10 percentage of inhibition	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	28.20 percentage of inhibition	—
Part 1: Ixazomib 1 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	39.33 percentage of inhibition	Standard Deviation 8.868
Part 1: Ixazomib 1 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	35.22 percentage of inhibition	Standard Deviation 8.592
Part 1: Ixazomib 1.33 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	46.73 percentage of inhibition	Standard Deviation 9.424
Part 1: Ixazomib 1.33 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	54.30 percentage of inhibition	Standard Deviation 4.058
Part 1: Ixazomib 1.76 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	62.20 percentage of inhibition	Standard Deviation 9.862
Part 1: Ixazomib 1.76 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	61.90 percentage of inhibition	Standard Deviation 9.042
Part 1: Ixazomib 2.34 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 11	70.40 percentage of inhibition	—
Part 1: Ixazomib 2.34 mg/m^2	Part 1: E Max: Maximum Observed Effect for Ixazomib	Cycle 1 Day 1	67.40 percentage of inhibition	—

Secondary

Part 1: Rac: Accumulation Ratio for Ixazomib

Rac was estimated as the ratio of AUC (0-72) on Day 11 and AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time 0 to 72 hours post-dose.

Time frame: Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose

Population: PK analysis population defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Ixazomib 0.125 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	2.210 ratio	—
Part 1: Ixazomib 0.25 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	5.160 ratio	—
Part 1: Ixazomib 0.5 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	3.290 ratio	—
Part 1: Ixazomib 1 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	2.996 ratio	Standard Deviation 1.5948
Part 1: Ixazomib 1.33 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	2.831 ratio	Standard Deviation 0.7228
Part 1: Ixazomib 1.76 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	3.086 ratio	Standard Deviation 0.4998
Part 1: Ixazomib 2.34 mg/m^2	Part 1: Rac: Accumulation Ratio for Ixazomib	6.130 ratio	—

Secondary

Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib

TEmax is the time to reach the Emax, equal to time (hours) to Emax.

Time frame: Part 1: Cycle 1 Days 1 and 11 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

Arm	Measure	Group	Value (MEDIAN)
Part 1: Ixazomib 0.125 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	24.000 hour
Part 1: Ixazomib 0.125 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	1.000 hour
Part 1: Ixazomib 0.25 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	0.100 hour
Part 1: Ixazomib 0.25 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	0.080 hour
Part 1: Ixazomib 0.5 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	0.100 hour
Part 1: Ixazomib 0.5 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	0.250 hour
Part 1: Ixazomib 1 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	0.100 hour
Part 1: Ixazomib 1 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	0.110 hour
Part 1: Ixazomib 1.33 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	0.080 hour
Part 1: Ixazomib 1.33 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	0.250 hour
Part 1: Ixazomib 1.76 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	0.080 hour
Part 1: Ixazomib 1.76 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	0.120 hour
Part 1: Ixazomib 2.34 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 11	0.100 hour
Part 1: Ixazomib 2.34 mg/m^2	Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib	Cycle 1 Day 1	0.080 hour

Secondary

Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib

T1/2 is the time required for half of the drug to be eliminated from the plasma.

Time frame: Part 1: Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part 1: Ixazomib 1 mg/m^2	Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib	171.90 hours	Standard Deviation 38.07
Part 1: Ixazomib 1.33 mg/m^2	Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib	144.69 hours	Standard Deviation 27.647
Part 1: Ixazomib 1.76 mg/m^2	Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib	104.84 hours	Standard Deviation 39.646
Part 1: Ixazomib 2.34 mg/m^2	Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib	90.80 hours	—

Secondary

Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC

The average data of Days 1 and 4 of Cycle 1 was reported.

Time frame: Cycle 1 Days 1 and 4: Predose and (from 4-20 hours) post-dose

Population: The tumor PK analysis set where Day 1 and 4 assessment were available. The tumor PK and PD analysis population includes all participants who provided a baseline tumor biopsy sample and 1 post-baseline tumor biopsy sample on Day 1 or Day 4.

Arm	Measure	Value (MEAN)	Dispersion
Part 1: Ixazomib 0.125 mg/m^2	Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC	525 nanogram per gram (ng/g)	Standard Deviation 342

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies

Conditions

Keywords

Brief summary

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

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

20S Proteasome Activity of Ixazomib in the Tumor Tissue

Expression of Biomarker (ATF-3) in Tumor Tissue

Number of Participants With Best Overall Response

Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib

Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration

Part 1: E Max: Maximum Observed Effect for Ixazomib

Part 1: Rac: Accumulation Ratio for Ixazomib

Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib

Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib

Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC