A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
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.
Checked against the public recordLast updated Nov 2, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: GDC-0941; Drug: erlotinib HCl
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationAurora, Colorado
- Study locationNew Brunswick, New Jersey
- Study locationAmsterdam
- Study locationUtrecht
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2016. Always confirm current availability with the study team.