Masitinib Plus Gemcitabine in Pancreatic Cancer

NCT03766295 | Completed Phase 3 FDA Drug

• 1 other identifier: AB12005
• Study Type: interventional
• Target: 377
• Locations: 8 countries
• Sites: 9

Brief Summary

The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Keywords

Pancreatic cancer; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall Survival (median)

  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 (2)

• Survival rates

  every 24 weeks

• Progression Free Survival

  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 at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.

Drug: Masitinib; Drug: Gemcitabine

Placebo & gemcitabine

ACTIVE COMPARATOR

Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
• Patient with pain related to the disease, as assessed by the investigator and the patient:
• Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
• Pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).
• \- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
• \. Chemotherapy naïve patient for the advanced/metastatic disease

You may not qualify if:

• Pregnant or nursing female patient

Sponsors & Collaborators

• AB Science: lead

Study Sites (9)

Hospital AZ Sint-Jan

Bruges, 8000, Belgium

Location

Polyclinique de Limoges site CHENIEUX

Limoges, 87000, France

Location

Centre Hospitalier de Longjumeau

Longjumeau, 91160, France

Location

General University Hospital of Patras

Pátrai, 26504, Greece

Location

Sanjeevani CBCC USA Cancer Hospital

Raipur, 492001, India

Location

Omsk Clinical oncology dispensary Omsk

Omsk, 644013, Russia

Location

National Oncology Institute

Bratislava, 833 10, Slovakia

Location

Institut Salah Azaiez de Cancerologie

Bab Saadoun, Tunisia

Location

Center of Surgical Innovations

Kiev, Ukraine

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

masitinib; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Joël Ezenfis, MD

  Centre Hospitalier de Longjumeau, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 6, 2018
• Study Start: July 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

UA (1); BE (1); FR (2); RU (1); SL (1); GR (1); TU (1); IN (1)