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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:July 2011
End Date:June 2015

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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

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.


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

- 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
We found this trial at
4
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