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

• ClinicalTrials.gov Identifier: NCT01301716
• Recruitment Status: Completed
• First Posted: February 23, 2011
• Last Update Posted: November 2, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Solid Cancers	Drug: GDC-0980; Drug: bevacizumab; Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: pemetrexed	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase Ib, Open-Label, Dose-Escalation 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
• Study Start Date: September 2011
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: A	Drug: GDC-0980; Oral escalating dose; Drug: carboplatin; Intravenous repeating dose; Drug: paclitaxel; Intravenous repeating dose
Experimental: B	Drug: GDC-0980; Oral escalating dose; Drug: bevacizumab; Intravenous repeating dose; Drug: carboplatin; Intravenous repeating dose; Drug: paclitaxel; Intravenous repeating dose
Experimental: C	Drug: GDC-0980; Oral escalating dose; Drug: cisplatin; intravenous repeating dose; Drug: pemetrexed; intravenous repeating dose

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events [ Time Frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first ]
2. Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study ]
3. Nature of adverse events [ Time Frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first ]
4. Nature of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study ]
5. Severity of adverse events [ Time Frame: Up to 30 days after last dose of study treatment ]

Secondary Outcome Measures :

1. Total exposure [ Time Frame: Up to 32 months or early study discontinuation ]
2. Maximum plasma concentration [ Time Frame: Up to 32 months or early study discontinuation ]
3. Time to maximum observed plasma concentration [ Time Frame: Up to 32 months or early study discontinuation ]
4. Plasma half-life [ Time Frame: Up to 32 months or early study discontinuation ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• For Arm C: Conditions that preclude the use of pemetrexed or cisplatin

Contacts and Locations

Locations

United States, California

Los Angeles, California, United States, 90025

United States, Florida

Tampa, Florida, United States, 33612

United States, Massachusetts

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02215

Spain

Madrid, Spain, 28050

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01301716
• Other Study ID Numbers: PIM4946g; GO01336 ( Other Identifier: Hoffmann-La Roche )
• First Posted: February 23, 2011
• Last Update Posted: November 2, 2016
• Last Verified: November 2016

Additional relevant MeSH terms:

Paclitaxel; Bevacizumab; Cisplatin; Carboplatin; Pemetrexed; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors