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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 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 104 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01564251
The ClinicalTrials.gov registry entry for NCT01564251 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 104 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 2 interventions - of which Gemcitabine is the first listed.
NCT01564251 reports 0 study locations.
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.
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