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

NCT02009423 | Terminated Phase 3 FDA Drug

• 1 other identifier: AB12004
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastro-Intestinal Stromal Tumour

Keywords

Gastro-Intestinal Stromal Tumour; GIST; Localized primary tumor; Adjuvant therapy.

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival (RFS)

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

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

Secondary Outcomes (1)

• Overall Survival (OS)

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

Study Arms (2)

Masitinib

EXPERIMENTAL

masitinib-treatment arm

Drug: Masitinib

Placebo

PLACEBO COMPARATOR

placebo-treatment arm

Drug: Placebo

Interventions

Masitinib DRUG

Masitinib

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• AB Science: lead

MeSH Terms

Interventions

masitinib

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: November 28, 2013
• First Posted: December 12, 2013
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 14, 2018

Record last verified: 2018-12