A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

Phase 1 Terminated 40 enrolled Genentech, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.

Timeline

Start: 2007-06
Primary completion: 2009-11
Completion: 2009-11

Outcome

Outcome not reported

Stopped: “The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.”

Publications

Shin YG, Jones SA, Murakami SC, Budha N, Ware J, Wong H, Buonarati MH, Dean B, Hop CE. Validation and application of a liquid chromatography-tandem mass spectrometric method for the determination of GDC-0152 in human plasma using solid-phase extraction. Biomed Chromatogr. 2013 Jan;27(1):102-10. doi: 10.1002/bmc.2754. Epub 2012 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GDC-0152	Protein / enzyme biologic	—	Intravenous

Indications

No indication recorded.