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NCT01485861 · ClinicalTrials.gov registry record · Phase 1
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 298
- Enrollment target
NCT01485861: Completed Phase 1 study, sponsored by Genentech.
NCT01485861 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 298 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (397% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01485861, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 298 participants
- Enrollment target
Study Summary
This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.
Primary Outcome
DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than \[\<\] 500 per microliter) lasting greater than (\>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyper
Interventions
- DRUG Placebo
- DRUG Ipatasertib
- DRUG Prednisone
- DRUG Abiraterone
- DRUG Apitolisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2012-01-11 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 1 |
What the finished NCT01485861 record still lists
NCT01485861 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (397% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01485861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01485861 about?
NCT01485861 is a clinical study titled "Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy". This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase i...
What is the current status of trial NCT01485861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 298 participants. The study started on 2012-01-11. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT01485861?
The interventions under investigation include: Placebo (DRUG), Ipatasertib (DRUG), Prednisone (DRUG), Abiraterone (DRUG), Apitolisib (DRUG).
Who is sponsoring clinical trial NCT01485861?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01485861's enrollment target sits among peer trials
298 134th of 2000 higher than 1,866 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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