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

Use our guide to learn which trials are right for you!

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
sites
1524
mi
from 91732
Rochester, MN
Click here to add this to my saved trials
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
5988
mi
from 91732
Barcelona,
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials