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A Phase Ib, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic 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 Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- Histologically or cytologically documented, locally advanced or metastatic solid
tumors for which standard therapy either does not exist or has proven ineffective or
intolerable

- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid
Tumors (RECIST)

- Life expectancy >= 12 weeks

- Adequate hematologic and end organ function

- Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

- History of prior significant toxicity from another MEK pathway inhibitor requiring
discontinuation of treatment

- History of prior significant toxicity from another PI3K pathway inhibitor requiring
discontinuation of treatment

- Allergy or hypersensitivity to components of the GDC-0973 or GDC-0941 formulations

- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in
Cycle 1

- Experimental therapy within 4 weeks prior to first dose of study drug treatment in
Cycle 1

- Major surgical procedure or significant traumatic injury within 4 weeks prior to
first dose of study drug treatment in Cycle 1, or anticipation of the need for major
surgery during the course of study treatment

- Prior anti-cancer therapy within 28 days before the first dose of study drug
treatment in Cycle 1

- History of diabetes requiring daily medication, or history of Grade >= 3 fasting
hyperglycemia

- Current severe, uncontrolled systemic disease

- History of clinically significant cardiac or pulmonary dysfunction

- History of malabsorption or other condition that would interfere with enteral
absorption

- Clinically significant history of liver disease (including cirrhosis), current
alcohol abuse, or current known active infection with HIV, hepatitis B virus, or
hepatitis C virus

- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics

- Active autoimmune disease

- Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive
weeks prior to enrollment

- Pregnancy, lactation, or breastfeeding

- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms

- No other history of or ongoing malignancy that would potentially interfere with the
interpretation of the pharmacodynamic or efficacy assays

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence and nature of dose-limiting toxicities

Outcome Time Frame:

Through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Iris Chan, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MEK4752g

NCT ID:

NCT00996892

Start Date:

November 2009

Completion Date:

August 2014

Related Keywords:

  • Solid Cancers
  • GDC0941
  • GDC0973
  • MEK
  • MEK Inhibitor
  • PI3K
  • PI3K Inhibitor
  • PI3 Kinase
  • PI3 Kinase Inhibitor

Name

Location

Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Baltimore, Maryland  21287
Boston, Massachusetts  
Tulsa, Oklahoma