A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
In brief
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.
Key facts
- Study ID
- NCT00975182
- Run by
- Genentech, Inc.
- People needed
- 58
- Starts
- 2009-09-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Aurora, Colorado, United States
- Study site — New Brunswick, New Jersey, United States
- Study site — Amsterdam, Netherlands
- Study site — Utrecht, Netherlands
Full record on ClinicalTrials.gov
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