Inflammatory Myofibroblastic TumourNCT03085186
Treatment With Crizotinib Single Patient Expanded Access IND 134375
A study testing Crizotinib in people with Inflammatory Myofibroblastic Tumour, run by Jean M. Tersak, M.D..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 2 years, men only
- Conditions the study is for
- Inflammatory Myofibroblastic Tumour
- What is being tested?
- Crizotinib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 years
- Men only
- Child
Who may be able to join
- This treatment plan is intended for the use of Crizotinib in the treatment of a single patient with Inflammatory Myofibroblastic Tumour
Who cannot join
- Not applicable as Expanded Access only includes one patient
About this study
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.
- Conditions
- Inflammatory Myofibroblastic Tumour
- Being tested
- Crizotinib
- Medical subject headings
- Granuloma, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizotinibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Myofibroblastic TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jean M. Tersak, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Jean M. Tersak, M.D., University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085186
- Sponsor's protocol ID
- PRO17030033
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Crizotinib Single Patient Expanded Access IND 134375
- ClinicalTrials.gov ID
- NCT03085186
- Acronym / sponsor ID
- PRO17030033
- Conditions
- Inflammatory Myofibroblastic Tumour
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Jean M. Tersak, M.D.University, hospital or other
- Collaborators
- Pfizer
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 2 to 2 years
- Sex
- Male only
- Age groups
- Child
Key inclusion criteria (1 listed)
- This treatment plan is intended for the use of Crizotinib in the treatment of a single patient with Inflammatory Myofibroblastic Tumour
Key exclusion criteria (1 listed)
- Not applicable as Expanded Access only includes one patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crizotinib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
Related trials for Inflammatory Myofibroblastic Tumour
RecruitingPhase 1/2
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Locally Advanced Solid Tumors, Metastatic Solid Tumors
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma
Active, not recruitingPhase 4
Crizotinib Continuation Clinical Study
NSCLC, ALCL
RecruitingPhase 1/2
Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors
Anaplastic Large Cell Lymphoma, ALK-Positive, Inflammatory Myofibroblastic Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Crizotinib in people with Inflammatory Myofibroblastic Tumour, run by Jean M. Tersak, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.