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Clinical Trials/EUCTR2008-003883-20-DE
EUCTR2008-003883-20-DE
Active, not recruiting
Not Applicable

An open-label, multicenter, expanded access study of imatinib mesylate in adult patients with GIST in adjuvant setting after R0-resection

ovartis Pharma GmbH0 sites750 target enrollmentJuly 24, 2008
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Conditionsgastrointestinal stromal tumors - adjuvant treatment after surgical tumor resectionMedDRA version: 9.1Level: LLTClassification code 10051066Term: Gastrointestinal stromal tumour
DrugsGlivec Filmtabletten 400 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
gastrointestinal stromal tumors - adjuvant treatment after surgical tumor resection
Sponsor
ovartis Pharma GmbH
Enrollment
750
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 24, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ovartis Pharma GmbH

Eligibility Criteria

Inclusion Criteria

  • •Age \= 18 years
  • •Histological confirmed diagnosis of GIST with positive immunostaining for KIT (CD117\) on a tumor sample taken within 12 weeks of the study entry
  • •Complete gross resection of the tumor
  • •Risk of relapse documented as intermediate and high” according to NIH criteria:
  • •1\. High risk category:
  • •\- tumor size \> 10 cm; or
  • •\- mitotic rate \> 10/50HPF; or
  • •\- tumor size \> 5 cm \& mitotic rate \> 5/50 HPF
  • •2\. Intermediate risk category:
  • •\- tumor size less than 5 cm \& mitotic rate 6\-10/50HPF

Exclusion Criteria

  • •Prior participation in an adjuvant GIST trial
  • •Prior treatment with imatinib
  • •Treatment with any cytotoxic and/or investigational cytotoxic drug \= 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1
  • •Patients with known history of hypersensitivity against imatinib
  • •Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs
  • •Use of therapeutic coumarin derivatives (i.e. warfarin, acenoucumarol, phenprocoumon)
  • •Patients who have undergone major surgery \= 2 weeks prior to Visit 1 or who have not recovered from side effects of such surgery
  • •A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits
  • •Patients who are pregnant, breast feeding or women of childbearing potential (WOCBP). Post menopausal women must be amenorrheic for at least 12 months to be considered of non\-childbearing potential Women of reproductive potential, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following termination of the study.
  • •Patients unwilling or unable to comply with the protocol

Outcomes

Primary Outcomes

Not specified

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