A Phase Ia, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0152, an IAP Protein Antagonist, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies

Genentech, Inc.0 sites40 target enrollmentJune 2007

ConditionsSolid Cancers

InterventionsGDC-0152

DrugsGDC-0152

Overview

Phase: Phase 1
Intervention: GDC-0152
Conditions: Solid Cancers
Sponsor: Genentech, Inc.
Enrollment: 40
Primary Endpoint: Incidence and nature of dose-limiting toxicities
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

November 2009

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

A

Intervention: GDC-0152

Outcomes

Primary Outcomes

Incidence and nature of dose-limiting toxicities

Time Frame: Through study completion or early study discontinuation

Incidence, nature, and severity of adverse events

Time Frame: Through study completion or early study discontinuation

Secondary Outcomes

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