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NCT01564251 · ClinicalTrials.gov registry record · Phase 1
A Study of GDC-0575 Alone and in Combination With Gemcitabine in Participants With Refractory Solid Tumors or Lymphoma
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
NCT01564251: Completed Phase 1 study, sponsored by Genentech.
NCT01564251 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01564251, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
Study Summary
This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination with gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1, cohorts of participants will receive multiple ascending oral doses of GDC-0575 alone or in combination with intravenous gemcitabine. In Stage 2, participants will receive GDC-0575 orally in combination with intravenous gemcitabine at or below the maximum tolerated dose determined in Stage 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, up to approximately 5 years.
Interventions
- DRUG Gemcitabine
- DRUG GDC-0575
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2012-03-23 |
| Est. Completion | 2018-01-11 |
| Phase | Phase 1 |
What the finished NCT01564251 record still lists
NCT01564251 is an interventional study that assigns participants to a tested intervention. The registered 104 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 (73% higher).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01564251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01564251 about?
NCT01564251 is a clinical study titled "A Study of GDC-0575 Alone and in Combination With Gemcitabine in Participants With Refractory Solid Tumors or Lymphoma". This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination with gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1, cohorts of participants will receive ...
What is the current status of trial NCT01564251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2012-03-23. Estimated completion is 2018-01-11.
What interventions are being tested in trial NCT01564251?
The interventions under investigation include: Gemcitabine (DRUG), GDC-0575 (DRUG).
Who is sponsoring clinical trial NCT01564251?
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 NCT01564251's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 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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