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NCT00996892 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 1
- Development phase
- 178
- Enrollment target
NCT00996892: Clinical Trial Phase 1 study, sponsored by Genentech.
NCT00996892 is a Phase 1 study that was terminated before completion, run by Genentech. The registered enrollment target is 178 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (197% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996892, a Phase 1 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 178 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 dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.
Primary Outcome
DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non cli
Interventions
- DRUG Cobimetinib
- DRUG Pictilisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
Why NCT00996892 stopped before completion
NCT00996892 is an interventional study that assigns participants to a tested intervention. The registered 178 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 (197% higher).
The record links to 0 conditions, and to 2 interventions - of which Cobimetinib is the first listed.
NCT00996892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996892 about?
NCT00996892 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors". This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.
What is the current status of trial NCT00996892?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 178 participants. The study started on 2009-11. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00996892?
The interventions under investigation include: Cobimetinib (DRUG), Pictilisib (DRUG).
Who is sponsoring clinical trial NCT00996892?
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 NCT00996892's enrollment target sits among peer trials
178 311th of 2000 higher than 1,688 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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