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OpenTrials
Completed

NCT Number: NCT00998751

Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.

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Key information

Conditions

Gastro-intestinal Stromal Tumours

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lecesne

Villejuif, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral masitinib

Drug

7.5 mg/kg/day

Other names: AB1010

Primary outcomes

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

    Time frame: 2 months

Secondary outcomes

  1. Progression Free Survival

    Time frame: until disease progression

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2009
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.