A Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel and Carboplatin With or Without Bevacizumab in Patients With Solid Tumors
Status: Recruiting
Phase:
Diagnosis: Lung Cancer, GYN: Endometrial/Uterine Cancer, GYN: Ovarian, Fallopian, Peritoneal Cancer, GYN: Cervical Cancer
NCT ID: NCT01301716
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-419
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with paclitaxel and carboplatin with or without bevacizumab to patients with locally advanced or metastatic solid tumors.
Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI:
Pasi Janne, MD, PhD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Rebecca Heist, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Kelly Masone, 617-632-3383,
kmasone@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Christin Whalen, 617-582-7738,
cwhalen@partners.org
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically documented, incurable, locally advanced, or
metastatic solid malignancy
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement to use an effective form of contraception and to
continue its use for the duration of the study
- Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the
exception of prostate cancer (two rising PSA Levels that meet the criteria of
progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels
greater than the ULN)
Exclusion Criteria
- Current dyspnea at rest due to complications of advanced malignancy, or other
conditions requiring continuous supplemental oxygen
- Uncontrolled hypomagnesemia or hypokalemia
- History of Grade ≥ 3 fasting hyperglycemia
- Any condition requiring full-dose anticoagulants
- Known HIV infection
- Known untreated or active central nervous system (CNS) metastases
- Pregnancy, lactation, or breastfeeding
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to the first dose of study treatment or anticipation of need for major surgical
procedure during the course of the study
- For Arm B: Conditions that preclude the use of bevacizumab