A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Genentech

Status and phase

Completed

Phase 1

Conditions

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

Treatments

Drug: erlotinib HCl

Drug: GDC-0941

Study type

Interventional

Funder types

Industry

Identifiers

NCT00975182

GDC4626g

GO01301 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Pregnancy, lactation, or breastfeeding