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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT01613053
Other study ID # CAMN107DCN03
Secondary ID
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
Est. completion date
Est. primary completion date
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


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, 

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