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

NCT ID: NCT00975182

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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PI3K NSCLC Tarceva

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

Oral repeating dose

erlotinib HCl

Intervention Type DRUG

Oral repeating dose

Interventions

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GDC-0941

Oral repeating dose

Intervention Type DRUG

erlotinib HCl

Oral repeating dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Aurora, Colorado, United States

Site Status

New Brunswick, New Jersey, United States

Site Status

Amsterdam, , Netherlands

Site Status

Utrecht, , Netherlands

Site Status

Countries

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Italy United Kingdom United States Netherlands

Other Identifiers

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GO01301

Identifier Type: OTHER

Identifier Source: secondary_id

GDC4626g

Identifier Type: -

Identifier Source: org_study_id