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Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure

NCT04193553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-06-18

No results posted yet for this study

Summary

The primary objective is to compare the efficacy of lenvatinib plus Best Supportive Care versus Placebo plus Best Supportive Care in the treatment of patients with advanced GIST, after failure of imatinib and sunitinib.

Conditions

  • Gastro Intestinal Stromal Tumour

Interventions

DRUG

Lenvatinib

Lenvatinib will be administered continuously but patient's follow-up visits will be scheduled monthly. The starting dose of study treatment is 24mg, once daily, at the same time. Recommendations for dose reductions will be respected according to BI Lenvatinib. If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration. Study treatments will be continued until a treatment discontinuation criteria is met.

DRUG

Placebo

Placebo will be administered continuously but patient's follow-up visits will be scheduled monthly. The starting dose of study treatment is 24mg, once daily, at the same time. Recommendations for placebo dose reductions are the same as for Lenvatinib. If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration. Study treatments will be continued until a treatment discontinuation criteria is met. In case disease progression, patients in control arm could switch in the Lenvatinib + BSC arm.

OTHER

Best supportive care

At any time during the study, patients should receive best supportive care. Best Supportive care as medically indicated for the patient's well-being may be prescribed at the investigator's discretion. Based on the patient's condition, it may consist (but not limited) of analgesics, antibiotics, steroids, blood transfusion, antiemetics, antidepressants/anxiolytics, nutritional counselling, psychological support, palliative radiotherapy…

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Axel LE CESNE, Ph · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2024-01-30
Completion
2024-04-26

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04193553 on ClinicalTrials.gov