An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma

Genentech, Inc.0 sites10 target enrollmentJune 2011

ConditionsNon-Hodgkin's Lymphoma, Solid Tumor

InterventionsGDC-0349

DrugsGDC-0349

Overview

Phase: Phase 1
Intervention: GDC-0349
Conditions: Non-Hodgkin's Lymphoma, Solid Tumor
Sponsor: Genentech, Inc.
Enrollment: 10
Primary Endpoint: Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

December 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit
•Evaluable or measurable disease per RECIST v1.1 or IWG response criteria for patients with NHL and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels \>= 5 ng/mL measured \>= 2 weeks apart that meet the PSA, and Working Group criteria for progression prior to initiation of study treatment, and ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN \>= 2 weeks apart prior to initiation of study treatment.
•ECOG performance status of 0 or 1 at screening
•Life expectancy of \>= 12 weeks
•Adequate hematologic and organ function within 14 days prior to initiation of study treatment
•Documented willingness to use an effective means of contraception for both men and women while participating in the study and for 90 days after the last dose of GDC-0349
•Willingness to provide archival tumor tissue

Exclusion Criteria

•Leptomeningeal disease as the only manifestation of the current malignancy
•History of Type 1 or 2 diabetes requiring daily medication
•Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for \>= 3 months prior to initiation of study treatment
•Active congestive heart failure or ventricular arrhythmia requiring medication
•Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment
•Active infection requiring intravenous (IV) antibiotics
•Patients requiring any daily supplemental oxygen
•Uncontrolled hypomagnesemia or hypokalemia
•Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor
•Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

Arms & Interventions

A

Intervention: GDC-0349

Outcomes

Primary Outcomes

Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349

Time Frame: Up to 30 days

Secondary Outcomes

Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349(Up to 2 years)
Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349(Up to 30 days)