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NCT01362374 · ClinicalTrials.gov registry record · Phase 1
Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT01362374: Completed Phase 1 study, sponsored by Genentech.
NCT01362374 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362374, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of ipatasertib administered in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1, approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be evaluated to determine the maximum tolerated dose (MTD) of ipatasertib in a given combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to further characterize the safety and tolerability of ipatasertib in these combinations and to confirm a potential recommended Phase II dose of ipatasertib for each regimen. NOTE: Arms A, B, and C are closed.
Interventions
- DRUG Docetaxel
- DRUG Ipatasertib
- DRUG Leucovorin
- DRUG Enzalutamide
- DRUG 5-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2011-07-11 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 1 |
What the finished NCT01362374 record still lists
NCT01362374 is an interventional study that assigns participants to a tested intervention. The registered 122 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 (103% higher).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01362374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362374 about?
NCT01362374 is a clinical study titled "Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors". This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6 chemotherapy) (A...
What is the current status of trial NCT01362374?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2011-07-11. Estimated completion is 2020-10-16.
What interventions are being tested in trial NCT01362374?
The interventions under investigation include: Docetaxel (DRUG), Ipatasertib (DRUG), Leucovorin (DRUG), Enzalutamide (DRUG), 5-FU (DRUG).
Who is sponsoring clinical trial NCT01362374?
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 NCT01362374's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 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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