NCT01359696

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	GDC-0425	Oral escalating dose
DRUG	gemcitabine	Intravenous repeating dose

Timeline

• Start date: 2011-07-11
• Primary completion: 2014-05-29
• Completion: 2014-05-29
• First posted: 2011-05-25
• Last updated: 2017-04-12

Locations

3 sites across 2 countries: United States, France