CompletedPhase 1NCT00975182

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

StatusCompleted
PhasePhase 1
U.S. locations4
SponsorGenentech, Inc.
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

View original record ↗