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Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastro-intestinal Stromal Tumours

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Trial Information

Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)


Inclusion Criteria:



- Male or Female patients, age >18

- Life expectancy > 6 months

- Histological proven, metastatic, or locally advanced and non-operable, non-
pre-treated GIST.

- Patients having never received any tyrosine kinase inhibitor, including as adjuvant
therapy

- C-Kit (CD117) positive tumors detected immuno-histochemically

- Measurable tumor lesions with longest diameter >20 mm using conventional techniques
or >10 mm with spiral CT scan

Exclusion Criteria:

- Documented allergy to the similar drug of AB1010

- Inadequate organ function

- Patients with a history of any other malignancy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)

Outcome Time Frame:

2 months

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AB04016

NCT ID:

NCT00998751

Start Date:

June 2005

Completion Date:

June 2014

Related Keywords:

  • Gastro-intestinal Stromal Tumours
  • cKIT inhibitor
  • GIST
  • Gastrointestinal Stromal Tumors

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