NCT00975182CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 58
- Primary Endpoint
- Incidence, nature, and severity of adverse events
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Experimental
Intervention: GDC-0941 (Drug)
A
Experimental
Intervention: erlotinib HCl (Drug)
Outcomes
Primary Outcomes
Incidence, nature, and severity of adverse events
Time Frame: Through study completion or early study discontinuation
Tumor response
Time Frame: Assessed at periodic intervals
Secondary Outcomes
- PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)(Through study completion or early study discontinuation)
Investigators
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