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Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumor

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Trial Information

Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination


Five patients who are on treatment of imatinib and deriving clinical benefit after
CAMN107DBR01 study termination and written informed consent obtained will enter the trial,
all five patients will receive Glivec (8oomg per day) treatment until tumor progression [by
RECIST guidelines, version 1.0], unacceptable toxicity, death or withdrawal of consent.


Inclusion Criteria:



- Five patients who are on treatment of imatinib and deriving clinical benefit after
CAMN107DBR01 study termination and written informed consent obtained.

Exclusion Criteria:

- N/A.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jie Zhong, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ruijin Hospital of Shanghai Jiaotong University

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107DCN03

NCT ID:

NCT01613053

Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumor, GIST
  • Gastrointestinal Stromal Tumors

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