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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


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

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of adverse events

Outcome Time Frame:

Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PIM4946g

NCT ID:

NCT01301716

Start Date:

September 2011

Completion Date:

March 2014

Related Keywords:

  • Solid Cancers

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Boston, Massachusetts