Treatment With Crizotinib Single Patient Expanded Access IND 134375

August 28, 2017 updated by: Jean M. Tersak, M.D.

Two year old male with a new diagnosis of Inflammatory Myofibroblastic Tumour. The patient presented with 2 months of intermittent fever and 1-2 weeks of abdominal distention and constipation. An abdominal mass was palpable on exam and US concerning was for neoplasm of abdomen.

Treatment with Crizotinib will be utilized to reduce the size of the lesion and create more optimal tissue plains between vital structures prior to attempted surgical resection would greatly reduce potential morbidity for this patient.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • This treatment plan is intended for the use of Crizotinib in the treatment of a single patient with Inflammatory Myofibroblastic Tumour

Exclusion Criteria:

  • Not applicable as Expanded Access only includes one patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean M. Tersak, M.D.

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO17030033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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