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Clinical Trials/EUCTR2015-005437-53-IE
EUCTR2015-005437-53-IE
Active, not recruiting
Phase 1

A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies Study ITCC 053 - Crizotinib study

Erasmus Medical Center0 sites82 target enrollmentJune 7, 2018
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ConditionsMalignancies carrying a genetic alteration of ALK, MET or ROS1Therapeutic area: Diseases [C] - Cancer [C04]
DrugsXalkori 200 mg hard capsulesXalkori 250 mg hard capsules

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Malignancies carrying a genetic alteration of ALK, MET or ROS1
Sponsor
Erasmus Medical Center
Enrollment
82
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 7, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Histologically or cytologically confirmed diagnosis of ALCL
  • •Target gene aberration as defined as:
  • •o A point mutation in the kinase domain of ALK that results in an amino\-acid
  • •change, and is not a known polymorphism
  • •o An amplification of the ALK gene, defined as \=9 copies per cell, or 4 copies
  • •per haploid genome. When assessed by FISH, ALK amplification must be
  • •observed in focal clusters of tumor cells (not only single cells) or in more than
  • •one\-third of the tumor cells
  • •o A translocation in \>15% of the tumor cells (by break apart FISH\-assay)
  • •Disease involvement:

Exclusion Criteria

  • •Other serious illnesses or medical conditions
  • •Current uncontrolled infection
  • •History of allergic reactions to the compounds or their solvents
  • •Patients with known CNS metastases and/or primary CNS tumors and/or meningeal
  • •lymphoma involvement, defined as CNS3 status (patients with CNS2 are eligible)
  • •Concurrent use of drugs or foods that are known potent CYP3A4 inducers or inhibitors as
  • •well as medication with known QT\-prolongation
  • •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the
  • •absorption of crizotinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea,
  • •or malabsorption syndrome)

Outcomes

Primary Outcomes

Not specified

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