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Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1

NCT02034981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2024-02-28

No results posted yet for this study

Summary

This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).

For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.

Conditions

Interventions

DRUG

Crizotinib

Patients will receive oral crizotinib, daily continuously, until progression or unacceptable toxicity develops. -250 mg twice daily for adults ≥ 18 years of age * 280 mg/m² twice daily for children and adolescents aged from 1 to 17 (except ALCL). * 165 mg/m² twice daily for ALCL patients aged from 1 to 17.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Fondation ARC

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Gilles VASSAL · Gustave Roussy, Villejuif

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2019-06-30
Completion
2023-12-06

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02034981 on ClinicalTrials.gov