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A Phase 1/2 Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor


Phase 1/Phase 2
6 Years
21 Years
Open (Enrolling)
Both
Gastrointestinal Stromal Tumors

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Trial Information

A Phase 1/2 Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor


Inclusion Criteria:



- Histological diagnosis of GIST.

- Patients must have demonstrated either disease progression or intolerance to imatinib
mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain
imatinib in their country

- Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable
disease.

Exclusion Criteria:

- Current treatment with another investigational agent.

- Prior sunitinib treatment.

- Prior therapy with known risk for cardiovascular complications.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics- Estimated steady-state maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662

Outcome Time Frame:

Weeks 1-18

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181196

NCT ID:

NCT01396148

Start Date:

June 2012

Completion Date:

November 2019

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Children and young adults with GIST
  • sunitinib malate
  • pharmacokinetics
  • tumor response
  • overall survival
  • tumor KIT mutation status
  • Gastrointestinal Stromal Tumors

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Children's Hospital BostonBoston, Massachusetts  02115