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A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0068 in Combination With Either Docetaxel or Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

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Trial Information

A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0068 in Combination With Either Docetaxel or Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced Solid Tumors


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 (For Arms A and B) or two (For Arm C) 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 insulin

- Active ventricular arrhythmia requiring medication

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities (DLTs)

Outcome Time Frame:

Days 2-21 of Cycle 1 for Arm A; Days 1-14 of Cycles 1 and 2 for Arm B; and Days 1-28 of Cycle 1 for Arm C

Safety Issue:

No

Principal Investigator

Premal H. Patel, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PAM4983g

NCT ID:

NCT01362374

Start Date:

July 2011

Completion Date:

March 2013

Related Keywords:

  • Solid Cancers

Name

Location

Nashville, Tennessee  37203-1632
Boston, Massachusetts