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Pancreatic CancerPhase 3NCT00789633

Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

A Phase 3 study testing Masitinib and Gemcitabine in people with Pancreatic Cancer, run by AB Science at 68 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Masitinib and Gemcitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
353 participants
Where
68 sitesin 5 countries
Study dates
25 Nov 2008to 31 Aug 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
  2. Chemo naïve patients with advanced/metastatic disease
  3. Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
  4. Men and women, age >18 years
  5. Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
  6. Patient should be able and willing to comply with study visits and procedures as per protocol.
  7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.

Main Exclusion Criteria:

  1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer
  2. Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
  3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
  4. Treatment with any investigational agent within 4 weeks prior to baseline

Trial locations and contacts

68 sites in 5 countries.

68 sites in 5 countries

France37 sites

  • CHU Amiens

    Amiens, 80000

  • Hôpital Privé d'Antony

    Antony, 92160

  • Institut Sainte-Catherine

    Avignon, 84000

  • Hôpital Jean Minjoz

    Besançon

  • Hôpital Saint-André

    Bordeaux

  • CHU de la Cavale Blanche

    Brest, 29600

  • CHU de Caen

    Caen, 14000

  • CHU Hôtel Dieu

    Clermont-Ferrand, 63000

  • Groupement Hospitalier Universitaire Nord - Beaujon

    Clichy, 92

  • CHU Henri Mondor

    Créteil, 94000

  • CHU Henri Mondor

    Créteil

  • Hôpital Victor Jousselin

    Dreux

  • Centre Gastro-Loire

    Gien, 45500

  • Institut Daniel Hollard

    Grenoble, 38000

  • CHD Les Oudairies

    La Roche-sur-Yon, 85925

  • Hôpital André Mignot

    Le Chesnay, 78150

  • Hôpital Robert Boulin

    Libourne, 33500

  • Hôpital Claude Huriez

    Lille, 59000

  • Centre Hospitalier de Longjumeau

    Longjumeau, 91164

  • Hôpital Privé Jean Mermoz

    Lyon, 69000

  • Hôpital Edouard Herriot

    Lyon, 69003

  • Centre Léon Bérard

    Lyon

  • Assistance Publique des Hôpitaux de Marseille

    Marseille, 13000

  • Hôpital Saint Joseph

    Marseille, 13000

  • Centre Hospitalier Belfort - Montbéliard

    Montbéliard, 25200

  • CHU Hôtel Dieu

    Nantes, 44000

  • Centre Catherine de Sienne

    Nantes, 44200

  • Hôpital de la Source

    Orléans, 45000

  • Groupe Hospitalier Diaconesse Croix Saint Simon

    Paris, 75000

  • Hôpital Tenon

    Paris, 75020

  • Hôpital Hôtel Dieu

    Paris

  • Hôpital Saint-Joseph

    Paris

  • Polyclinique Francheville

    Périgueux, 24000

  • Hôpital Haut-Lévêque

    Pessac, 33600

  • Hôpital Hautepierre

    Strasbourg, 67200

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54500

  • Hôpital Paul Brousse

    Villejuif, 94800

Other trials in France

United States12 sites

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Medical & Surgical Specialists

    Galesburg, Illinois, 61401

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Eastern Connecticut Hematology and Oncology (ECHO)

    Norwich, Connecticut, 06360

  • MD Anderson

    Orlando, Florida, 32806

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Berkshire Hematology Oncology

    Pittsfield, Massachusetts, 01201

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Metro MN CCOP

    Saint Louis Park, Minnesota, 55416

Other trials in United States

Czechia7 sites

  • Teaching Hospital Brno-Bohunice

    Brno, 625 00

  • Hospital Chomutov

    Chomutov, 430 12

  • Oncology Surgery

    Kutná Hora, 284 30

  • Department of Oncology Teaching Hospital Olomouc

    Olomouc, 775 20

  • Teaching Hospital Královské

    Prague, 100 34

  • Teaching Hospital Na Bulovce

    Prague, 180 81

  • Hospital na Homolce

    Prague, 5 150 30

Other trials in Czechia

Lebanon7 sites

  • Hotel Dieu de France

    Beirut

  • Makassed General Hospital Tarik Jadide

    Beirut

  • Rafik Hariri University Hospital

    Beirut

  • Saint Georges Hospital UMC

    Beirut

  • Middle East Institute of Health- Bsaleem

    Metn

  • Saint Joseph Hospital Baouchrieh

    Metn

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

Romania5 sites

  • Municipal Clinical Hospital

    Arad, 310013

  • County Hospital

    Baia Mare, 430031

  • Emergency Clinical Hospital

    Constanța, 900591

  • Pelica Impex SRL Hospital

    Pelica Impex, 410548

  • County Hospital

    Satu Mare, 440056

Other trials in Romania

About this study

Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

Read the detailed description

Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.

Being tested
Masitinib, Placebo, Gemcitabine
Keywords
Pancreatic cancer, Advanced pancreatic cancer, Metastatic pancreatic cancer, Gemcitabine, Chemo-naive
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MasitinibDrug

    Also called AB1010

    Masitinib at 9 mg/kg/day given orally twice daily

  • PlaceboDrug

    Matching placebo given orally twice daily

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine at 1000 mg/m2 by intravenous infusion

Study groups in NCT00789633
Study groupRoleWhat they receive
Masitinib & gemcitabineExperimentalParticipants receive masitinib (9 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.
Receives: Drug: Masitinib; Drug: Gemcitabine
Placebo & gemcitabinePlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From day of randomization to the date of death, assessed up to 60 months

Secondary outcomes (2)

  1. Survival rate

    Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.

    Measured: Every 24 weeks, assessed up to 60 months

  2. Progression Free Survival (PFS)

    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 the investigator on CT scan according to RECIST 1.1 criteria.

    Measured: From day of randomization to disease progression or death, whichever came first, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study start25 Nov 2008
  3. Primary completion23 Dec 2011
  4. Study completion31 Aug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00789633
Sponsor's protocol ID
AB07012
Status last verified
Dec 2018
First submitted
12 Nov 2008
Last updated
17 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moye L, Piquemal D, Ritter D, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Hammel P. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Ann Oncol. 2015 Jun;26(6):1194-1200. doi: 10.1093/annonc/mdv133. Epub 2015 Apr 9.

    PubMed 25858497

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Masitinib and Gemcitabine in people with Pancreatic Cancer, run by AB Science at 68 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in France, United States, Czechia, Lebanon, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From day of randomization to the date of death, assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00789633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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