Safety and Pharmacology Of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01362374
First received: May 26, 2011
Last updated: August 4, 2014
Last verified: August 2014

May 26, 2011
August 4, 2014
July 2011
March 2015   (final data collection date for primary outcome measure)
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Days 2-21 of Cycle 1 for Arm A; Days 1-14 of Cycles 1 and 2 for Arm B; Days 1-28 of Cycle 1 for Arm C; and Days 1 to 35 of Cycle 1 for Arm D ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) [ Time Frame: Days 2-21 of Cycle 1 for Arm A; Days 1-14 of Cycles 1 and 2 for Arm B; Days 1-28 of Cycle 1 for Arm C; and Days 1 to 35 of Cycle 1 for Arm D ] [ Designated as safety issue: No ]
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Days 2-21 of Cycle 1 for Arm A; and Days 1-14 of Cycles 1 and 2 for Arm B ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) [ Time Frame: Days 2-21 of Cycle 1 for Arm A; and Days 1-14 of Cycles 1 and 2 for Arm B ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01362374 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Nature adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Severity of adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Nature adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Severity of adverse events and laboratory abnormalities graded per NCI CTCAE v4.03 [ Time Frame: Until 30 days after last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Pharmacology Of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors
A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology Of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0068 administe red in combination with either docetaxel, mFOLFOX6, paclitaxel or enzalutamide i n patients with advanced or metastatic solid tumors for which standard therapy e ither does not exist or has proven ineffective or intolerable.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
  • Drug: paclitaxel
    Oral repeating dose
  • Drug: docetaxel
    Repeating intravenous dose
  • Drug: GDC-0068
    Oral escalating dose
  • Drug: mFOLFOX6
    Repeating intravenous dose
  • Drug: enzalutamide
    Oral repeating dose
  • Experimental: C
    Interventions:
    • Drug: paclitaxel
    • Drug: GDC-0068
  • Experimental: A
    Interventions:
    • Drug: docetaxel
    • Drug: GDC-0068
  • Experimental: B
    Interventions:
    • Drug: GDC-0068
    • Drug: mFOLFOX6
  • Experimental: D
    Interventions:
    • Drug: GDC-0068
    • Drug: enzalutamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
  • Histologically or cytologically documented advanced or metastatic solid tumors for which established therapy either does not exist or has proven ineffective or intolerable, with the following exceptions:

    • For Arm C, patients with metastatic triple-negative (HER2 negative, estrogen receptor negative, progesterone receptor negative) breast cancer are eligible, regardless of whether they have received prior chemotherapy
    • For the Expansion Cohort A of Arm C, a minimum of 10 patients with HER2-negative metastatic breast cancer who have had no more than 1 prior chemotherapy regimen for metastatic diseases are eligible
    • For Arm D, patients with metastatic CRPC who have either received docetaxel or are not good candidates to receive docetaxel are eligible
  • Life expectancy >= 12 weeks
  • Adequate hematologic and end organ function
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use for the duration of the study and for 4 months after last dose of study treatment (for females) and 6 months after last dose of study treatment (for males)

Exclusion Criteria:

  • Prior anti-cancer therapy that fulfills the following criteria: a total of more than three (Arms A and B) or two (Arms C and D) prior cytotoxic chemotherapy regimens, high-dose chemotherapy requiring stem-cell support, and irradiation to >= 25% of bone marrow-bearing areas
  • Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of GDC-0068. Exceptions are kinase inhibitors approved by local regulatory authorities, which may be used within 2 weeks prior to initiation of GDC-0068, provided that any clinically-relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor.
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0068
  • History of Type 1 or Type 2 diabetes requiring regular medication
  • Grade >/= 2 heart failure or history of unstable angina
  • History of clinically significant ventricular arrhythmias or active ventricular arrhythmia requiring medication
  • For Arm D only: History of seizure, unexplained loss of consciousness, transient ischemic attack within 12 months of enrollment, cerebral vascular accident, and any brain metastases
Both
18 Years and older
No
Contact: Reference Study ID Number: PAM4983g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   France,   Spain,   United Kingdom
 
NCT01362374
PAM4983g, GO27845
Not Provided
Genentech
Genentech
Not Provided
Study Director: Premal H. Patel, M.D., Ph.D. Genentech
Genentech
August 2014

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