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

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

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Julien Grenier, Dr; AB Science

More Information

• Responsible Party: AB Science
• ClinicalTrials.gov Identifier: NCT02490488
• Other Study ID Numbers: AB12008
• First Posted: July 3, 2015
• Last Update Posted: December 8, 2020
• Last Verified: April 2020

Keywords provided by AB Science:

ovarian cancer; tyrosine kinase inhibitor

Additional relevant MeSH terms:

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