Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01317641

Enrollment

136

Registered

2011-03-17

Start date

2011-03-31

Completion date

2013-07-31

Last updated

2017-03-29

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

Conditions

Prostate Cancer

Brief summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Interventions

DRUGODM-201

ODM-201 administered orally daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written informed consent * Histologically confirmed adenocarcinoma of prostate * Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy * Progressive metastatic disease * Adequate bone marrow, hepatic, and renal function

Exclusion criteria

* Known metastases in the brain * History of other malignancy within the previous 5 years * Known gastrointestinal disease or procedure that affects the absorption * Not able to swallow the study drug

Design outcomes

Primary

Measure	Time frame	Description
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	Up to 28 days for each cohort	A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	Up to 28 days for each cohort	The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)

Secondary

Measure	Time frame	Description
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	3 months	Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	3 months	Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group	3 months	Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	3 months	Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	3 months	Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	3 months	Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group	3 months	Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group	3 months	Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group	3 months	Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose	AUC(0-8h)
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose	—
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	1 day	—
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose	AUC(0-8h)
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose	—
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	1 day	—

Countries

Czechia, Estonia, Finland, France, United Kingdom, United States

Participant flow

Recruitment details

Participants were enrolled at 23 hospitals in Europe and in the USA from Apr 5, 2011 to Mar 12, 2013

Pre-assignment details

136 participants participated in the study, including 24 enrolled in Phase 1 and 112 in Phase 2 randomly assigned to 200 mg, 400 mg or 1400 mg daily doses and stratified by previous chemotherapy and treatment with CYP17 inhibitor. Two participants assigned to treatment did not start ODM-201, and were therefore excluded from analyses populations.

Participants by arm

Arm	Count
Phase 1, 200mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.	4
Phase 1, 400mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.	7
Phase 1, 600mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.	3
Phase 1, 1000mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.	4
Phase 1, 1400mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.	3
Phase 1, 1800mg/Day ODM-201 Dose escalation. Participants received twice daily of oral ODM-201 continuously.	3
Phase 2 (200mg/Day ODM-201) Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously	38
Phase 2 (400mg/Day ODM-201) Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.	37
Phase 2 (1400mg/Day ODM-201) Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.	35
Total	134

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG003	FG006	FG007	FG008
Overall Study	Adverse Event	0	1	1	2	1	0
Overall Study	Disease progression	0	0	0	0	3	4
Overall Study	Not treated	0	0	0	0	1	1
Overall Study	Protocol Violation	1	0	0	0	0	0
Overall Study	Withdrawal by Subject	0	0	0	1	0	0

Baseline characteristics

Characteristic	Phase 1, 200mg/Day ODM-201	Phase 1, 400mg/Day ODM-201	Phase 1, 600mg/Day ODM-201	Phase 1, 1000mg/Day ODM-201	Phase 1, 1400mg/Day ODM-201	Phase 1, 1800mg/Day ODM-201	Phase 2 (200mg/Day ODM-201)	Phase 2 (400mg/Day ODM-201)	Phase 2 (1400mg/Day ODM-201)	Total
Age, Continuous	73 years STANDARD_DEVIATION 1.4	71.9 years STANDARD_DEVIATION 8.5	65.3 years STANDARD_DEVIATION 3.5	65.8 years STANDARD_DEVIATION 11.2	67.7 years STANDARD_DEVIATION 5.5	67.7 years STANDARD_DEVIATION 3.2	68.3 years STANDARD_DEVIATION 7	69.1 years STANDARD_DEVIATION 7.4	71.3 years STANDARD_DEVIATION 8	69.4 years STANDARD_DEVIATION 7.4
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	4 Participants	7 Participants	3 Participants	4 Participants	3 Participants	3 Participants	38 Participants	37 Participants	35 Participants	134 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	4 / 4	5 / 7	2 / 3	4 / 4	3 / 3	2 / 3	33 / 38	35 / 37	27 / 35
serious Total, serious adverse events	0 / 4	2 / 7	0 / 3	1 / 4	1 / 3	0 / 3	2 / 38	3 / 37	4 / 35

Outcome results

Primary

Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose

The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)

Time frame: Up to 28 days for each cohort

Population: Safety population included all participants in Phase 1 who received any study drug.

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	0 DLTs
Phase 1: ODM-201 400 mg/Day	Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	0 DLTs
Phase 1: ODM-201 600 mg/Day	Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	0 DLTs
Phase 1: ODM-201 1000 mg/Day	Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	0 DLTs
Phase 1: ODM-201 1400 mg/Day	Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	0 DLTs
Phase 1: ODM-201 1800 mg/Day	Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose	0 DLTs

Primary

Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)

A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.

Time frame: Up to 28 days for each cohort

Population: Safety population included all participants in Phase 1 who received any study drug.

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	0 events
Phase 1: ODM-201 400 mg/Day	Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	0 events
Phase 1: ODM-201 600 mg/Day	Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	0 events
Phase 1: ODM-201 1000 mg/Day	Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	0 events
Phase 1: ODM-201 1400 mg/Day	Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	0 events
Phase 1: ODM-201 1800 mg/Day	Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)	0 events

Secondary

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group

Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor

Time frame: 3 months

Population: Evaluable chemotherapy-naïve and CYP17i-naïve patients

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	6 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	9 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	6 participants
Phase 1: ODM-201 1800 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group	2 participants

Secondary

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group

Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor

Time frame: 3 months

Population: Evaluable post-chemotherapy and CYP17i-naïve patients

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	5 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	4 participants
Phase 1: ODM-201 1800 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group	0 participants

Secondary

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group

Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor

Time frame: 3 months

Population: Evaluable post-CYP17 inhibitor patients

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group	0 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group	3 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group	0 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group	1 participants

Secondary

Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group

Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.

Time frame: 3 months

Population: Evaluable Chemotherapy-naïve and CYP17i-naïve patients

Arm	Measure	Group	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR	1 participants
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR+SD	9 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR	4 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR+SD	6 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR+SD	2 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR+SD	2 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR	1 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group	RECIST response CR+PR+SD	2 participants

Secondary

Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group

Time frame: 3 months

Population: Evaluable Post-chemotherapy and CYP17i-naïve patients

Arm	Measure	Group	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR	1 participants
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR+SD	5 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR+SD	3 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR+SD	0 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR+SD	4 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR	1 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group	RECIST response CR+PR+SD	1 participants

Secondary

Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group

Time frame: 3 months

Population: Evaluable Post-CYP17i patients

Arm	Measure	Group	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	RECIST response CR+PR+SD	5 participants
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	RECIST response CR+PR+SD	9 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	RECIST response CR+PR	2 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	RECIST response CR+PR	0 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group	RECIST response CR+PR+SD	6 participants

Secondary

Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group

Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan

Time frame: 3 months

Population: Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group	10 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group	7 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group	6 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group	1 participants

Secondary

Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group

Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan

Time frame: 3 months

Population: Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group	5 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group	4 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group	1 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group	0 participants
Phase 1: ODM-201 1400 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group	7 participants

Secondary

Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group

Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan

Time frame: 3 months

Population: Evaluable post-CYP17i patients with bone metastasis at baseline

Arm	Measure	Value (NUMBER)
Phase 1: ODM-201 200 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group	5 participants
Phase 1: ODM-201 400 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group	9 participants
Phase 1: ODM-201 600 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group	1 participants
Phase 1: ODM-201 1000 mg/Day	Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group	6 participants

Secondary

Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state

AUC(0-8h)

Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Population: PK population (Day 8)

Arm	Measure	Value (MEAN)	Dispersion
Phase 1: ODM-201 200 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	11754.23 h*ng/mL	Standard Deviation 5161.8
Phase 1: ODM-201 400 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	15501.56 h*ng/mL	Standard Deviation 2755.85
Phase 1: ODM-201 600 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	24902.56 h*ng/mL	Standard Deviation 12129.79
Phase 1: ODM-201 1000 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	29980.83 h*ng/mL	Standard Deviation 11658.75
Phase 1: ODM-201 1400 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	63531.81 h*ng/mL	Standard Deviation 15798.3
Phase 1: ODM-201 1800 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state	64435.97 h*ng/mL	Standard Deviation 22930.3

Secondary

Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state

AUC(0-8h)

Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Population: PK population (Day 8)

Arm	Measure	Value (MEAN)	Dispersion
Phase 1: ODM-201 200 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	6387.27 h*ng/mL	Standard Deviation 742.01
Phase 1: ODM-201 400 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	10973.66 h*ng/mL	Standard Deviation 5939.78
Phase 1: ODM-201 600 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	14205.99 h*ng/mL	Standard Deviation 2127.26
Phase 1: ODM-201 1000 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	14817.39 h*ng/mL	Standard Deviation 4190.48
Phase 1: ODM-201 1400 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	31764.82 h*ng/mL	Standard Deviation 8714.06
Phase 1: ODM-201 1800 mg/Day	Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state	28884.44 h*ng/mL	Standard Deviation 4900.6

Secondary

Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state

Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Population: PK population (Day 8)

Arm	Measure	Value (MEAN)	Dispersion
Phase 1: ODM-201 200 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	1850.00 ng/mL	Standard Deviation 654.83
Phase 1: ODM-201 400 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	2491.43 ng/mL	Standard Deviation 328.86
Phase 1: ODM-201 600 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	3963.33 ng/mL	Standard Deviation 1935.21
Phase 1: ODM-201 1000 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	4643.33 ng/mL	Standard Deviation 1340.01
Phase 1: ODM-201 1400 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	9336.67 ng/mL	Standard Deviation 2054.27
Phase 1: ODM-201 1800 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state	9406.67 ng/mL	Standard Deviation 3165.38

Secondary

Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state

Time frame: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose

Population: PK population (Day 8)

Arm	Measure	Value (MEAN)	Dispersion
Phase 1: ODM-201 200 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	1011.67 ng/mL	Standard Deviation 168.84
Phase 1: ODM-201 400 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	1757.57 ng/mL	Standard Deviation 858.72
Phase 1: ODM-201 600 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	2033.00 ng/mL	Standard Deviation 277.59
Phase 1: ODM-201 1000 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	2392.33 ng/mL	Standard Deviation 406.63
Phase 1: ODM-201 1400 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	4459.00 ng/mL	Standard Deviation 1163.1
Phase 1: ODM-201 1800 mg/Day	Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state	4235.00 ng/mL	Standard Deviation 617.8

Secondary

Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1

Time frame: 1 day

Population: PK population (Day 1)

Arm	Measure	Value (MEDIAN)	Dispersion
Phase 1: ODM-201 200 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	3.00 h	Standard Deviation 1.63
Phase 1: ODM-201 400 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	1.52 h	Standard Deviation 1.33
Phase 1: ODM-201 600 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	3.00 h	Standard Deviation 0.92
Phase 1: ODM-201 1000 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	5.04 h	Standard Deviation 2.05
Phase 1: ODM-201 1400 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	3.00 h	Standard Deviation 1.15
Phase 1: ODM-201 1800 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1	5.00 h	Standard Deviation 0.55

Secondary

Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1

Time frame: 1 day

Population: PK population (Day 1)

Arm	Measure	Value (MEDIAN)	Dispersion
Phase 1: ODM-201 200 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	3.00 h	Standard Deviation 1.63
Phase 1: ODM-201 400 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	3.00 h	Standard Deviation 0.73
Phase 1: ODM-201 600 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	3.00 h	Standard Deviation 0.92
Phase 1: ODM-201 1000 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	5.08 h	Standard Deviation 1.47
Phase 1: ODM-201 1400 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	3.00 h	Standard Deviation 1.15
Phase 1: ODM-201 1800 mg/Day	Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1	5.00 h	Standard Deviation 1.51

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026

Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

Conditions

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

Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose

Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group

Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group

Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group

Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group

Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group

Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group

Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group

Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group

Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state

Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state

Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state

Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state

Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1

Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1