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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

This study is currently recruiting participants.
Verified November 2012 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01301716
First received: February 18, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  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: bevacizumab
Drug: carboplatin
Drug: GDC-0980
Drug: paclitaxel
Drug: pemetrexed
Drug: cisplatin
 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Genentech:

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 ]

Estimated Enrollment: 48
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: carboplatin
Intravenous repeating dose
Drug: GDC-0980
Oral escalating dose
Drug: paclitaxel
Intravenous repeating dose
Experimental: B Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: GDC-0980
Oral escalating dose
Drug: paclitaxel
Intravenous repeating dose
Experimental: C Drug: GDC-0980
Oral escalating dose
Drug: pemetrexed
intravenous repeating dose
Drug: cisplatin
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301716

Contacts
Contact: Please reference Study ID Number: PIM4946g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90025
United States, Florida
Recruiting
Tampa, Florida, United States, 33612-9497
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
Recruiting
Boston, Massachusetts, United States, 02114
Spain
Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01301716     History of Changes
Other Study ID Numbers: PIM4946g, GO01336
Study First Received: February 18, 2011
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013