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

Genentech

Status and phase: Completed; Phase 1

Conditions: Solid Cancers

Treatments: Drug: bevacizumab; Drug: paclitaxel; Drug: carboplatin; Drug: GDC-0980; Drug: pemetrexed; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301716

PIM4946g

GO01336 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: paclitaxel

Drug: GDC-0980

Drug: carboplatin

B

Experimental group

Treatment:

Drug: paclitaxel

Drug: GDC-0980

Drug: carboplatin

Drug: bevacizumab

C

Experimental group

Treatment:

Drug: GDC-0980

Drug: pemetrexed

Drug: cisplatin