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 - Full Text View

Purpose

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	Intervention	Phase
Solid Cancers	Drug: GDC-0980 Drug: bevacizumab Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: pemetrexed	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Cisplatin Paclitaxel Carboplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Nature of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study ] [ Designated as safety issue: No ]
Severity of adverse events [ Time Frame: Up to 30 days after last dose of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total exposure [ Time Frame: Up to 32 months or early study discontinuation ] [ Designated as safety issue: No ]
Maximum plasma concentration [ Time Frame: Up to 32 months or early study discontinuation ] [ Designated as safety issue: No ]
Time to maximum observed plasma concentration [ Time Frame: Up to 32 months or early study discontinuation ] [ Designated as safety issue: No ]
Plasma half-life [ Time Frame: Up to 32 months or early study discontinuation ] [ Designated as safety issue: No ]


Enrollment:	65
Study Start Date:	September 2011
Study Completion Date:	August 2014
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301716

Locations


United States, California

Los Angeles, California, United States, 90025
United States, Florida

Tampa, Florida, United States, 33612-9497
United States, Massachusetts

Boston, Massachusetts, United States, 02215

Boston, Massachusetts, United States, 02114
Spain

Madrid, Spain, 28050

Sponsors and Collaborators

Genentech, Inc.

Investigators


Study Director:	Clinical Trials	Genentech, Inc.

More Information

No publications provided


Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT01301716 History of Changes
Other Study ID Numbers:	PIM4946g, GO01336
Study First Received:	February 18, 2011
Last Updated:	February 4, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Bevacizumab Carboplatin Cisplatin Paclitaxel Pemetrexed Angiogenesis Inhibitors Angiogenesis Modulating Agents Antimetabolites Antimetabolites, Antineoplastic Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic	Enzyme Inhibitors Folic Acid Antagonists Growth Inhibitors Growth Substances Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators

ClinicalTrials.gov processed this record on February 27, 2015