Safety and Pharmacology of GDC-0068 in Combination With Either Docetaxel or Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced Solid Tumors

        Status: Recruiting
        Diagnosis: Solid Tumor/Phase I
        NCT ID: NCT01362374 (View complete trial on
        DFCI Protocol ID: 11-277


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


        Conducting Institutions:
        Massachusetts General Hospital

        Overall PI:
        Steven Isakoff, MD, PhD, Massachusetts General Hospital

        Site-responsible Investigators:

        Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

        Eligibility Criteria

        Inclusion Criteria: - 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 - 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 30 days after last dose of study drug Exclusion Criteria: - Prior anti-cancer therapy that fulfills the following criteria: a total of more than three 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 - Active ventricular arrhythmia requiring medication
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