NCT05009927

Brief Summary

This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST. In the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease. In the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
8mo left

Started Jan 2022

Longer than P75 for phase_2

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

August 2, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 2, 2021

Last Update Submit

August 31, 2023

Conditions

Metastatic Gastrointestinal Stromal Tumor (GIST)C-KIT MutationAdvanced Gastrointestinal Stromal Tumor (GIST)

Keywords

Gastrointestinal Stromal Tumors (GIST)Tyrosine kinase inhibitorMaintenance therapyBayesian designKIT +ImatinibRandomisation study

Outcome Measures

Primary Outcomes (1)

  • Progression-free-rate at 6 months (PFR 6m)

    Defined as the rate of patients with a non-progressive disease 6 months after randomization

    6 months after randomization

Secondary Outcomes (7)

  • Progression-free-survival (PFS)

    5 years (i.e. at the the time of last patient last visit)

  • Overall Survival (OS)

    5 years (i.e. at the the time of last patient last visit)

  • Safety profile

    5 years (i.e. at the the time of last patient last visit)

  • Quality of Life (QoL)

    5 years (i.e. at the the time of last patient last visit)

  • Progression-free survival rechallenge

    5 years (i.e. at the the time of last patient last visit)

  • +2 more secondary outcomes

Study Arms (2)

Imatinib interruption

EXPERIMENTAL

Immediate interruption of imatinib until progressive disease. In case of 1st relapse, imatinib will be reintroduced at 400mg/d and further increased at 800mg/d in case of 2nd relapse after re-introduction.

Drug: Imatinib tablets

Imatinib maintenancce

NO INTERVENTION

Maintenance of imatinib at the last dose routinely taken by the patient in the 10-year period prior to randomization (either 300 or 400 mg once daily). In case of progressive disease imatinib will be increased up to 800mg/day.

Interventions

Imatinib tabletsDRUG

Imatinib interruption

Also known as: Glivec
Imatinib interruption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years of age;
  • Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
  • Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;
  • Patient with controlled disease (without any progression under imatinib);
  • Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;
  • Covered by a medical/health insurance;
  • Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

You may not qualify if:

  • Patient concurrently using other approved or investigational antineoplastic agents;
  • Patient with GIST harboring the mutation D842V in PDGFRA;
  • Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
  • Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;
  • Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
  • Major surgery within 2 weeks prior to study entry.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Pregnant or breastfeeding woman
  • Patient requiring tutorship or curatorship or patient deprivied of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Besançon

Besançon, 25000, France

RECRUITING

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

CHU Dupuytren

Limoges, 87042, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13273, France

NOT YET RECRUITING

Institut Curie

Paris, 75005, France

NOT YET RECRUITING

CHU de Reims

Reims, 51100, France

RECRUITING

Centre Eugène Marquis

Rennes, 35042, France

NOT YET RECRUITING

Institut de Cancérologie de l'Ouest - Site Réné Gauducheau

Saint-Herblain, 44805, France

NOT YET RECRUITING

Institut de Cancérologie Lucien NEUWIRTH

Saint-Paul-en-Jarez, 42270, France

NOT YET RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

NOT YET RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

NOT YET RECRUITING

Institut Goustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Jean-Yves BLAY, Pr

    Centre Léon Bérard, Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Yves BLAY, Pr

CONTACT

+33 4 78 78 27 57jean-yves.blay@lyon.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 18, 2021

Study Start

January 3, 2022

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

FR(13)