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 July 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01362374
First received: May 26, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Solid Cancers
Drug: paclitaxel
Drug: docetaxel
Drug: GDC-0068
Drug: mFOLFOX6
Drug: enzalutamide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C Drug: paclitaxel
Oral repeating dose
Drug: GDC-0068
Oral escalating dose
Experimental: A Drug: docetaxel
Repeating intravenous dose
Drug: GDC-0068
Oral escalating dose
Experimental: B Drug: GDC-0068
Oral escalating dose
Drug: mFOLFOX6
Repeating intravenous dose
Experimental: D Drug: GDC-0068
Oral escalating dose
Drug: enzalutamide
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01362374

Contacts
Contact: Reference Study ID Number: PAM4983g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
San Francisco, California, United States, 94115
United States, Florida
Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02130
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States, 48109-0934
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89148
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
Recruiting
Norfolk, Virginia, United States, 23502
France
Completed
Villejuif, France, 94805
Spain
Completed
Barcelona, Spain, 08035
Completed
Valencia, Spain, 46010
United Kingdom
Completed
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Genentech
Investigators
Study Director: Premal H. Patel, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01362374     History of Changes
Other Study ID Numbers: PAM4983g, GO27845
Study First Received: May 26, 2011
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Oxaliplatin
Docetaxel
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014