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NCT01562275 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT01562275: Completed Phase 1 study, sponsored by Genentech.
NCT01562275 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01562275, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Primary Outcome
DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) Grade (G) ≥3 febrile neutropenia, b) G ≥4 neutropenia (absolute neutrophil count \[ANC\] \<500/ microliter \[μL\]) lasting \>5 days , c) G ≥4 thrombocytopenia lasting \>2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or alkaline phosphatase (ALP) lasting \>3 days, f) Hepatic transaminases \>3 × Upper Limit of Normal (ULN) and an increase in
Interventions
- DRUG Ipatasertib
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01562275 record still lists
NCT01562275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Ipatasertib is the first listed.
NCT01562275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01562275 about?
NCT01562275 is a clinical study titled "A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors". This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascendi...
What is the current status of trial NCT01562275?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2012-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01562275?
The interventions under investigation include: Ipatasertib (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT01562275?
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 NCT01562275's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 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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