NCT00998751

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

8 years

First QC Date

October 19, 2009

Last Update Submit

December 8, 2018

Conditions

Gastro-intestinal Stromal Tumours

Keywords

cKIT inhibitorGIST

Outcome Measures

Primary Outcomes (1)

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

    2 months

Secondary Outcomes (1)

  • Progression Free Survival

    until disease progression

Study Arms (1)

masitinib (AB1010)

EXPERIMENTAL

oral masitinib 7.5 mg/kg/day

Drug: oral masitinib

Interventions

oral masitinibDRUG

7.5 mg/kg/day

Also known as: AB1010
masitinib (AB1010)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Documented allergy to the similar drug of AB1010
  • Inadequate organ function
  • Patients with a history of any other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lecesne

Villejuif, France

Location

Related Publications (1)

  • Le Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.

    PMID: 20211560RESULT

MeSH Terms

Interventions

masitinib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

June 1, 2005

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

FR(1)