A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

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.

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

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers

Intervention / Treatment
-----------------
* Drug: GDC-0941
* Drug: erlotinib HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: GDC-0941<br>* Oral repeating dose<br>Drug: erlotinib HCl<br>* Oral repeating dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, nature, and severity of adverse events |  | Through study completion or early study discontinuation | 
| Tumor response |  | Assessed at periodic intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations) |  | Through study completion or early study discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PI3K, NSCLC, Tarceva