NCT01875705

A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

• 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, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	GDC-0994	Escalating doses of GDC-0994 until maximum tolerated dose is reached
DRUG	GDC-0994	Recommended dose determined in Stage I-Dose Escalation phase, until disease progression

Timeline

• Start date: 2013-06-21
• Primary completion: 2016-09-23
• Completion: 2016-09-23
• First posted: 2013-06-12
• Last updated: 2018-04-06

Locations

4 sites across 2 countries: United States, France