Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers Clinical Trial
Official title:
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
| Verified date | November 2016 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation | No | |
| Primary | Tumor response | Assessed at periodic intervals | No | |
| Secondary | PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations) | Through study completion or early study discontinuation | No |