Masitinib Plus Gemcitabine in Pancreatic Cancer

Conditions

• Locally Advanced or Metastatic Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Masitinib — DRUG
• Gemcitabine — DRUG
• Placebo — DRUG

Study Details

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.

Key Dates

Start date

Jul 31, 2014

Status verified

Dec 2020

Primary completion

Dec 31, 2020

Completion

Dec 31, 2020

Study Design

Enrollment

377 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Masitinib & gemcitabine
  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.
• Active Comparator: Placebo & gemcitabine
  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.

Primary Outcome Measure

Overall Survival (median) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]