A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
- Interventions
- Registration Number
- NCT00975182
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A GDC-0941 - A erlotinib HCl -
- Primary Outcome Measures
Name Time Method Incidence, nature, and severity of adverse events Through study completion or early study discontinuation Tumor response Assessed at periodic intervals
- Secondary Outcome Measures
Name Time Method PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations) Through study completion or early study discontinuation