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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01301716
First received: February 18, 2011
Last updated: October 6, 2014
Last verified: October 2014

February 18, 2011
October 6, 2014
September 2011
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01301716 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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 cisp latin to patients with locally advanced or metastatic solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
  • Drug: GDC-0980
    Oral escalating dose
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: carboplatin
    Intravenous repeating dose
  • Drug: cisplatin
    intravenous repeating dose
  • Drug: paclitaxel
    Intravenous repeating dose
  • Drug: pemetrexed
    intravenous repeating dose
  • Experimental: A
    Interventions:
    • Drug: GDC-0980
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: B
    Interventions:
    • Drug: GDC-0980
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: C
    Interventions:
    • Drug: GDC-0980
    • Drug: cisplatin
    • Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT01301716
PIM4946g, GO01336
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP