Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Gastrointestinal Stromal Tumor Clinical Trial

— MACS2226  

Official title:

Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01613053
• Other study ID #: CAMN107DCN03
• Status: No longer available
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: April 23, 2015

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Description:

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

N/A

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Glivec
800 mg per day

Locations

Country	Name	City	State
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Guang zhou
China	Novartis Investigative Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China,