GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
NCT ID: NCT01332604
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2011-07-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
GDC-0980
Oral escalating dose
capecitabine
Oral repeating dose
B
GDC-0980
Oral escalating dose
bevacizumab
Intravenous repeating dose
mFOLFOX6
Intravenous repeating dose
Interventions
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GDC-0980
Oral escalating dose
bevacizumab
Intravenous repeating dose
capecitabine
Oral repeating dose
mFOLFOX6
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* History of stroke or transient ischemic attacks within 6 months prior to the first dose of study treatment
* Significant vascular disease within 6 months prior to the first dose of study treatment
* History of hemoptysis within 1 month prior to the first dose of study treatment
* Patients with one or more pulmonary tumor masses with evidence of cavitation
* Evidence of bleeding diathesis or significant coagulopathy
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of study treatment
* History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment
* Clinical signs or symptoms of GI obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding
* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* The presence of an ulcerating breast cancer tumor will not render a patient ineligible
* Proteinuria
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Los Angeles, California, United States
Aurora, Colorado, United States
Rochester, Minnesota, United States
Barcelona, Barcelona, Spain
Countries
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Other Identifiers
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GO00883
Identifier Type: OTHER
Identifier Source: secondary_id
PIM4945g
Identifier Type: -
Identifier Source: org_study_id