drugset / Trial / NCT01106599

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT01106599 ↗

Phase 1 Completed 61 enrolled Genentech, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.

Timeline

Start
2010-04
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GDC-0623 Unknown — Oral

Indications

No indication recorded.