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A Phase Ib, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of GDC-0973 and GDC-0068 in Patients With Locally Advanced or Metastatic Solid Tumors


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

Thank you

Trial Information

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of GDC-0973 and GDC-0068 in Patients With Locally Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- Histologically or cytologically documented locally advanced or metastatic solid
tumors for which standard therapies either do not exist or have 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

Exclusion Criteria:

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

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

- Anti-cancer therapy within 28 days prior to first dose of study drug, except as
stated in protocol

- History of type I or type II diabetes mellitus requiring insulin

- Current severe, uncontrolled systemic disease (e.g. clinically significant
cardiovascular, pulmonary, or metabolic disease)

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

- Active autoimmune disease

- Pregnant or lactating women

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

- History of glaucoma

- History of retinal vein occlusion

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of dose-limiting toxicities

Outcome Time Frame:

approximately 24 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GE28079

NCT ID:

NCT01562275

Start Date:

April 2012

Completion Date:

December 2014

Related Keywords:

  • Neoplasms
  • MEK
  • GDC0973
  • Akt inhibitor
  • MEK inhibitor
  • GDC0068
  • Akt
  • Neoplasms

Name

Location

Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Boston, Massachusetts