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
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer | Drug: Masitinib Drug: Gemcitabine Drug: Placebo | Phase 2 Phase 3 |
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 |
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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.
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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.
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Drug: Gemcitabine
Other Name: Gemzar Drug: Placebo Other Name: Placebo Oral Tablet |
- 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.
- 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 |
Main inclusion criteria:
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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).
- Patient with adequate organ function per laboratory tests evaluations
Main exclusion criteria:
- Patient intolerant to gemcitabine
- Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)
- Pregnant or nursing female patient

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
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 |
Principal Investigator: | Julien Grenier, Dr | AB Science |
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 |
ovarian cancer tyrosine kinase inhibitor |
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 |