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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01301716
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301716


Locations
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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
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01301716    
Other Study ID Numbers: PIM4946g
GO01336 ( Other Identifier: Hoffmann-La Roche )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Paclitaxel
Bevacizumab
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