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Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients

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ClinicalTrials.gov Identifier: NCT02490488
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief Summary:
The objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Masitinib Drug: Gemcitabine Drug: Placebo Phase 2 Phase 3

Detailed Description:
Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine as compared with single agent gemcitabine in advanced or metastatic epithelial ovarian cancer patients who are refractory to platinum treatment. This is an open-label, randomized, active-controlled, phase 2/3 study. The study's primary efficacy measure will be overall survival. Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal. The study design is a two-stage adaptive design, meaning that it includes a prospectively planned opportunity for modification of one or more specified aspects of the study (for example patient enrollment).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of Masitinib in Combination With Gemcitabine Versus Gemcitabine Alone in Advanced/Metastatic Epithelial Ovarian Cancer Patients in Second Line Being Refractory to First Line Platinum Treatment or in Third Line
Actual Study Start Date : April 2014
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Masitinib & gemcitabine
Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine 1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion.
Drug: Masitinib
Other Name: AB1010

Drug: Gemcitabine
Other Name: Gemzar

Placebo Comparator: Placebo & gemcitabine
Participants receive placebo (6 mg/kg/day), given orally twice daily, plus gemcitabine 1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion.
Drug: Gemcitabine
Other Name: Gemzar

Drug: Placebo
Other Name: Placebo Oral Tablet




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]
    Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.


Secondary Outcome Measures :
  1. Overall Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]
    Progression Free Survival (PFS) [Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months] Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by CT scan according to RECIST criteria recommendations.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria:

  1. Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer), which is either:

    • First line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy)
    • First line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy);
    • Candidate to third line of treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line).
  2. Patient with adequate organ function per laboratory tests evaluations

Main exclusion criteria:

  1. Patient intolerant to gemcitabine
  2. Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)
  3. Pregnant or nursing female patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490488


Locations
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Algeria
Centre hospitalo-universitaire de Beni Messous
Algiers, Algeria, 16340
France
Institut Sainte Catherine
Avignon, France, 84000
Russian Federation
City Oncology Clinic
St.-Petersburg, Russian Federation, 198255
Spain
Complejo Hospitalario Universitario de Santiago
Santiago, Spain, 15706
Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
United Kingdom
University Hospital Coventry
Coventry, United Kingdom, CV2 2DX
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Julien Grenier, Dr AB Science
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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT02490488    
Other Study ID Numbers: AB12008
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: April 2020
Keywords provided by AB Science:
ovarian cancer
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs