Phase 2
Completed N=136
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT01317641 ↗Enrolled (actual)
136
Serious AEs
9.7%
Results posted
Mar 2017
Primary outcomePrimary: Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT) — 0; 0; 0; 0 events
Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group |
6; 9; 1; 1; 6; 2 | — |
| SECONDARY Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group |
5; 1; 1; 1; 4; 0 | — |
| SECONDARY Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group |
0; 3; 0; 1 | — |
| SECONDARY Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group |
1; 4; 0; 1; 0; 9 | — |
| SECONDARY Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group |
1; 0; 0; 1; 0; 5 | — |
| SECONDARY Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group |
0; 2; 0; 5; 9; 6 | — |
| SECONDARY Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group |
10; 7; 1; 6; 1 | — |
| SECONDARY Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group |
5; 4; 1; 0; 7 | — |
| SECONDARY Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group |
5; 9; 1; 6 | — |
| SECONDARY Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state |
6387.27; 10973.66; 14205.99; 14817.39; 31764.82; 28884.44 | — |
| SECONDARY Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state |
1011.67; 1757.57; 2033.00; 2392.33; 4459.00; 4235.00 | — |
| SECONDARY Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1 |
3.00; 3.00; 3.00; 5.08; 3.00; 5.00 | — |
| SECONDARY Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state |
11754.23; 15501.56; 24902.56; 29980.83; 63531.81; 64435.97 | — |
| SECONDARY Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state |
1850.00; 2491.43; 3963.33; 4643.33; 9336.67; 9406.67 | — |
| SECONDARY Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1 |
3.00; 1.52; 3.00; 5.04; 3.00; 5.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01317641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.