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NCT01440504 Clinical Trial

Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

Ovarian Cancer Clinical Trial

— ABT737 exvivo  

Official title:
Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01440504
Other study ID # ABT-737 ex vivo
Secondary ID
Status Completed
Phase Phase 2
First received September 15, 2011
Last updated February 6, 2013
Start date April 2010
Est. completion date January 2013

Study information
Verified date February 2013
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient aged over 18 years

- Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses

- Surgery of any initial chemotherapy naive

- Patient information and signed informed consent

Exclusion Criteria:

- A person deprived of liberty or under guardianship

- Insufficient tumor samples of ovarian cancer.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• culture ex vivo with exposure to different therapeutic agents alone or in combination.
When tumor resection, tumor specimens of ovarian cancer will be made towards a culture ex vivo with exposure to different therapeutic agents alone or in combination.

Locations
Country Name City State
France Centre François Baclesse Caen

Sponsors (2)
Lead Sponsor Collaborator
Centre Francois Baclesse GRECAN

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of apoptotic cells 2 years No
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