Status:
COMPLETED
A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00975182
Start Date
September 1 2009
End Date
September 1 2014
Last Update
November 2 2016
Active Locations (4)
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1
Aurora, Colorado, United States, 80045
2
New Brunswick, New Jersey, United States, 08903
3
Amsterdam, Netherlands, 1066 EC
4
Utrecht, Netherlands, 3508 GA