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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGDC-0941 and erlotinib HCl

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 2, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Genentech, Inc.

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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.

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