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

Phase 1

Terminated

• Conditions: Solid Cancers
• Interventions: Drug: GDC-0152

• Registration Number: NCT00977067
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-09-12
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-15
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	GDC-0152	-

Primary Outcome Measures

Name	Time	Method
Incidence and nature of dose-limiting toxicities	Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events	Through study completion or early study discontinuation

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance)	Through study completion or early study discontinuation