Trial record 1 of 1 for:    NCT01694277
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A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01694277
First received: August 22, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Masitinib
Drug: Sunitinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death


Secondary Outcome Measures:
  • Time to Progression [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Time to Progression from the date of randomization until disease progression

  • Overall Progression Free Survival (PFS) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    From the date of randomization to disease progression or death

  • Survival rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    from the date of randomization until death

  • Objective Response Rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Partial response or total Response

  • Control Disease Rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Disease Control documented partial response (PR), complete response (CR) or stable disease (SD


Estimated Enrollment: 208
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Masitinib
masitinib at 12 mg/kg/day
Drug: Masitinib
12 mg/kg/day
Active Comparator: Sunitinib
sunitinib at 50 mg/day
Drug: Sunitinib
50 mg/day

Detailed Description:

GISTs are uncommon visceral sarcomas that arise predominantly in the gastrointestinal tract. Most GIST cells are positive for c-kit (CD117), a cell surface antigen corresponding to the Stem Cell Factor (SCF) receptor. The receptor has an intracellular tyrosine kinase (TK) joined by a juxtamembrane domain. It is hypothesized that all malignant GIST cells harbor a mutation of c-kit, resulting in the activation of c-kit and cell division and tumour growth.

Drugs that can selectively inhibit TKs are likely to be of benefit in GISTs. Masitinib (AB1010) is a TK inhibitor, selectively and effectively inhibiting c-kit. Imatinib is also a TK inhibitor indicated in the treatment of GIST. It might be associated with side effects and patients might develop a resistance to treatment over time. Based on pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate in the second line treatment of patients with GIST after progression with imatinib.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with histological proven metastatic GIST or non-operable locally advanced GIST
  2. Patient with measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according to RECIST 1.1
  3. Patient with C-kit (CD117) positive tumour detected immuno-histochemically
  4. Patient after progression with to imatinib at the dose of 400 mg as first line treatment. Resistance Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment
  5. Patient with ECOG ≤ 2
  6. Patient with adequate organ functions
  7. Patient with life expectancy > 6 months
  8. Male or female patient, age >18 years
  9. Patient with a BMI > 18 kg/m² and weighing at least 40 kg
  10. Male and female patient of child bearing potential, (for female entering the study after a menstrual period and who have a negative pregnancy test at baseline) 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.
  11. Patient able and willing to comply with study procedures as per protocol
  12. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures

Exclusion Criteria:

  1. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
  2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
  3. - Patient presenting with cardiac disorders defined by at least one of the following conditions:

    • Patient with recent cardiac history (within 6 months) of:

      • Acute coronary syndrome
      • Acute heart failure (class III or IV of the NYHA classification)
      • Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    • Patient with cardiac failure class III or IV of the NYHA classification
    • Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    • Syncope without known aetiology within 3 months
    • Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
  4. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
  5. Pregnant, or nursing female patient

Previous treatment

  1. Known hypersensitivity to sunitinib or masitinib or to any of the excipients
  2. Patient previously treated with a dose of imatinib > 400mg
  3. Patient intolerant to imatinib
  4. Previous treatment with sunitinib or kinase inhibitor other than imatinib

    Wash-out

  5. Treatment with any investigational agent within 4 weeks prior to baseline
  6. Previous imatinib treatment should be permanently discontinued within 4 days prior randomisation and patient should have recovered from potential toxicity related to imatinib
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694277

Contacts
Contact: Axel Le Cesne, M.D., Ph.D. +33 1 42 11 43 16 lecesne@igr.fr

Locations
France
Institut Bergonié Recruiting
Bordeaux, France, 33000
Sponsors and Collaborators
AB Science
  More Information

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01694277     History of Changes
Other Study ID Numbers: AB11002
Study First Received: August 22, 2012
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AB Science:
Gastrointestinal Stromal Tumour
GIST
non-resectable
metastatic
second line treatment
resistance to imatinib

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Imatinib
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014