A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
Phase 1
Completed
- Conditions
- Solid Cancers
- Interventions
- Registration Number
- NCT01301716
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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
- For Arm C: Conditions that preclude the use of pemetrexed or cisplatin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A GDC-0980 - B GDC-0980 - C GDC-0980 - B bevacizumab - A carboplatin - A paclitaxel - B carboplatin - B paclitaxel - C cisplatin - C pemetrexed -
- Primary Outcome Measures
Name Time Method Incidence of adverse events Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first Severity of adverse events Up to 30 days after last dose of study treatment Incidence of dose limiting toxicities (DLTs) Up to 21 days from Last Patient In (LPI) in Stage 1 of study Nature of adverse events Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first Nature of dose limiting toxicities (DLTs) Up to 21 days from Last Patient In (LPI) in Stage 1 of study
- Secondary Outcome Measures
Name Time Method Total exposure Up to 32 months or early study discontinuation Maximum plasma concentration Up to 32 months or early study discontinuation Time to maximum observed plasma concentration Up to 32 months or early study discontinuation Plasma half-life Up to 32 months or early study discontinuation