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

NCT02490488 | Completed Phase 2 DMC

• 1 other identifier: AB12008
• Study Type: interventional
• Target: 248
• Locations: 6 countries
• Sites: 6

Brief Summary

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

Conditions

Ovarian Cancer

Keywords

ovarian cancer; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  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.

  From day of randomization to death, assessed for a maximum of 60 months

Secondary Outcomes (1)

• Overall Progression Free Survival (PFS)

  From day of randomization to disease progression or death, assessed for a maximum of 60 months

Study Arms (2)

Masitinib & gemcitabine

EXPERIMENTAL

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; Drug: Gemcitabine

Placebo & gemcitabine

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Masitinib DRUG

Also known as: AB1010

Masitinib & gemcitabine

Gemcitabine DRUG

Also known as: Gemzar

Masitinib & gemcitabine; Placebo & gemcitabine

Placebo DRUG

Also known as: Placebo Oral Tablet

Placebo & gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AB Science: lead

Study Sites (6)

Centre hospitalo-universitaire de Beni Messous

Algiers, 16340, Algeria

Location

Institut Sainte Catherine

Avignon, 84000, France

Location

City Oncology Clinic

Saint Petersburg, 198255, Russia

Location

Complejo Hospitalario Universitario de Santiago

Santiago, 15706, Spain

Location

Lviv State Oncological Regional Treatment and Diagnostic Center

Lviv, 79031, Ukraine

Location

University Hospital Coventry

Coventry, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

masitinib; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Julien Grenier, Dr

  AB Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: July 3, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-04

Locations

UA (1); GB (1); RU (1); ES (1); AL (1); FR (1)