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GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

NCT01332604•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically documented locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist
•Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A)
•Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B)

Exclusion Criteria

•Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to \>= 25% of bone marrow-bearing areas
•Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy
•Known deficiency of dihydropyrimidine dehydrogenase (DPD)
•Bisphosphonate therapy for symptomatic hypercalcemia
•Known untreated or active central nervous system (CNS) metastases
•Pregnancy, lactation, or breastfeeding
•For Arm B:
•Inadequately controlled hypertension
•Prior history of hypertensive crisis or hypertensive encephalopathy
•History of myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment
+12 more criteria

Locations (4)

Los Angeles, California, United States

Aurora, Colorado, United States

Rochester, Minnesota, United States

Barcelona, Barcelona, Spain

Key Dates

Start Date

July 1, 2011

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Solid Cancers

Interventions

GDC-0980

DRUG

bevacizumab

DRUG

capecitabine

DRUG

mFOLFOX6

DRUG

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

NCT07186842

Advanced Solid Cancers

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RECRUITINGNA

Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

NCT03514368

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An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.

Real-life Performance Evaluation of the LiFlow X-ray Platform

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers