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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 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 122 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01362374
The ClinicalTrials.gov registry entry for NCT01362374 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01362374 reports 0 study locations.
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.
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