A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Genentech, Inc.0 sites58 target enrollmentSeptember 2009

ConditionsNon-Squamous Non-Small Cell Lung Cancer, Solid Cancers

InterventionsGDC-0941 erlotinib HCl

DrugsGDC-0941 erlotinib HCl

Overview

Phase: Phase 1
Intervention: GDC-0941
Conditions: Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
Sponsor: Genentech, Inc.
Enrollment: 58
Primary Endpoint: Incidence, nature, and severity of adverse events
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 Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

September 2014

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

•Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
•Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
•Adequate organ function as assessed by laboratory tests
•Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
•Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria

•Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
•Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)
•History of Grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication
•Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
•History of clinically significant cardiac or pulmonary dysfunction
•History of malabsorption syndrome or other condition that would interfere with enteral absorption
•Clinically significant history of liver disease
•Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
•Active autoimmune disease and/or need for corticosteroid therapy
•Known brain metastases that are untreated, symptomatic, or require therapy