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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events

Outcome Time Frame:

Up to 30 days after last dose of study treatment

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PIM4945g

NCT ID:

NCT01332604

Start Date:

July 2011

Completion Date:

June 2013

Related Keywords:

  • Solid Cancers

Name

Location

Alexandria, Minnesota  56308
Fountain Valley, California  92708
Denver, Colorado