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CREATE: Cross-tumoral Phase 2 With Crizotinib

NCT01524926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2023-12-11

No results posted yet for this study

Summary

The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.

Conditions

  • Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma
  • Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor
  • Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1
  • Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma
  • Locally Advanced and/or Metastatic Clear Cell Sarcoma
  • Locally Advanced and/or Metastatic Alveolar Rhabdomyosarcoma

Interventions

DRUG

Crizotinib (PF-02341066)

For patients of 15yo and older, Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie; for patients younger than 15yo, 280 mg/m²/dose BID, with reductions allowed to 80% as first reduction and to 60% as second reduction respectively of the initial dose.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-12-06
Completion
2022-10-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Slovakia
  • Slovenia
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01524926 on ClinicalTrials.gov