NCT01564251

A Study of GDC-0575 Alone and in Combination With Gemcitabine in Participants With Refractory Solid Tumors or Lymphoma

An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Solid Tumor

Interventions

Type	Name	Description
DRUG	GDC-0575	Participants will receive GDC-0575 orally at a starting dose of 15 mg.
DRUG	Gemcitabine	Participants will receive gemcitabine intravenously at a dose of 1000 mg/m\^2 and/or 500 mg/m\^2.

Timeline

• Start date: 2012-03-23
• Primary completion: 2018-01-11
• Completion: 2018-01-11
• First posted: 2012-03-27
• Last updated: 2020-02-25

Locations

7 sites across 2 countries: United States, France