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Gastro-Intestinal Stromal TumourPhase 3NCT02009423

Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence

A Phase 3 study testing Masitinib in people with Gastro-Intestinal Stromal Tumour, run by AB Science.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastro-Intestinal Stromal Tumour
What is being tested?
Masitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7 participants
Where
No sites listed yet
Study dates
Jul 2015to Nov 2015
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

Who may be able to join

  • Patient with histologic diagnosis of localized, primary GIST
  • Patient with measurable primary tumor lesion using conventional techniques or spiral CT scan assessed before tumor resection
  • Patient stopped imatinib as adjuvant therapy without progression OR patient not eligible for imatinib as adjuvant therapy
  • Patient with a high risk of recurrence, i.e., patients with primary tumor diameter > 5 cm and mitotic count > 5/50 HPF, or tumor diameter > 10 cm and any mitotic count, or tumor of any size with mitotic count > 10/50 HPF, or tumors that have ruptured into the peritoneal cavity
  • Patient without peritoneal or distant metastasis
  • Patient with c-kit (CD117) positive primary tumor detected immuno-histochemically
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  • Patient after gross tumor resection (regardless of microscopic margins) within the past 14-70 days after surgery (R0 resection: negative microscopic margins or R1 resection: positive microscopic margins)
  • Patient free of tumor by post-operative imaging that included a baseline chest x-ray (or chest CT) and a post-operative abdomen and pelvis CT scan with intravenous and oral contrast or MRI with intravenous contrast within 28 days before the randomization
  • Patient with ECOG ≤ 2
  • Patient with adequate organ functions:
  • Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
  • Hemoglobin ≥ 10 g/dL
  • Platelets (PTL) ≥ 75 x 109/L
  • AST/ALT ≤ 3x ULN
  • Gamma GT < 2.5 x ULN
  • Bilirubin ≤ 1.5x ULN
  • Normal creatinine or if abnormal creatinine, creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
  • Albumin > 1 x LLN
  • Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
  • Patient with life expectancy > 3 months
  • Male or female patient, age >18 years
  • Patient weight > 40 kg and BMI > 18 kg/m²
  • Male and female patient of child bearing potential 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. Female patient of child bearing potential must have a negative pregnancy test at screening and baseline
  • Patient able and willing to comply with study procedures as per protocol
  • Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment
  • Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent
  • Patient covered by insurance

Who cannot join

  • Patient with metastases of the primary GIST tumor
  • 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
  • Patient progressed under imatinib as adjuvant therapy
  • Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
  • Patient presenting with cardiac disorders defined by at least one of the following conditions:
  • Patient with recent cardiac history (within 6 months) of:
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  • 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 etiology within 3 months
  • Uncontrolled hypertension or symptomatic hypertension, where hypertension is defined by systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg and uncontrolled means that SBP lower than 140 mmHg and DBP lower than 90 mmHg are not achieved despite anti-hypertensive drugs, whatever the reason of failure (inadequate treatment, poor compliance, secondary hypertension or resistant hypertension).
  • 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
  • Pregnant, or nursing female patient
  • Previous treatment
  • 1. Patient previously treated with chemotherapy, radiation therapy, or investigational treatment following surgery
  • Wash-out
  • Treatment with any investigational agent within 4 weeks prior to Baseline visit
  • For patients treated with imatinib as adjuvant therapy, end of imatinib treatment must be between 5 days and 12 weeks prior to baseline

About this study

Official title: A Prospective, Multicenter, Randomised, Double-blinded, Placebo-controlled, Two-parallel Groups, Phase III Study to Compare the Efficacy and Safety of Masitinib to Placebo in Patients With Localized, Primary Gastrointestinal Stromal Tumor (GIST) After Complete Surgery and With High Risk of Recurrence

The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence.

Read the detailed description

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day with respect to placebo in the treatment of patients with localized, primary gastrointestinal stromal tumor (GIST) after complete surgery and with high risk of recurrence.

Being tested
Masitinib, Placebo
Keywords
Gastro-Intestinal Stromal Tumour, GIST, Localized primary tumor, Adjuvant therapy.

What participants receive

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

  • MasitinibDrug

  • PlaceboDrug

Study groups in NCT02009423
Study groupRoleWhat they receive
MasitinibExperimentalmasitinib-treatment arm
Receives: Drug: Masitinib
PlaceboPlacebo comparatorplacebo-treatment arm
Receives: Drug: Placebo

What is being measured

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

  1. Recurrence Free Survival (RFS)

    e.g. from date of randomization until the date of first documented progression

    Measured: Until tumor recurrence (e.g. up to 24 months)

Secondary outcomes (1)

  1. Overall Survival (OS)

    e.g. from the date of randomization to the date of documented death

    Measured: until death of the patient (e.g. up to 24 months)

Timeline

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

  1. First posted12 Dec 2013 (estimated)
  2. Study startJul 2015
  3. Primary completionNov 2015
  4. Study completionNov 2015

Why it stopped: Sponsor decision based on portfolio prioritization

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
Double blind
Who is masked
Participant, Investigator
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02009423
Sponsor's protocol ID
AB12004
Status last verified
Dec 2018
First submitted
28 Nov 2013
Last updated
14 Dec 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Masitinib in people with Gastro-Intestinal Stromal Tumour, run by AB Science.

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

Who may be eligible to take part?

The sponsor lists 27 inclusion and 20 exclusion criteria. 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: stopped early, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.

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?

Recurrence Free Survival (RFS) (time frame: Until tumor recurrence (e.g. up to 24 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 NCT02009423.

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 14 Dec 2018.

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