FLT3-ITD MutationNCT03620318
Individual Patient Compassionate Use of Crenolanib
A study testing Crenolanib besylate in people with FLT3-ITD Mutation and FLT3/TKD Mutation, run by Arog Pharmaceuticals, Inc. at 1 site in Italy.
Trial summary
Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- FLT3-ITD Mutation, FLT3/TKD Mutation, PDGFR-Alpha D842V
- What is being tested?
- Crenolanib besylate
- How many people
- Not given
- Where
- 1 siteItaly
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options
- Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug
Who cannot join
- Subject is eligible for enrollment in an ongoing clinical trial
- Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation
Trial locations and contacts
1 site in 1 country.
Italy1 site
- Available
Ospedale Policlinico San Martino
Genova
Emanuele Angelucci, MD
About this study
Official title: Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Mutations, PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 (FLT3) Mutations
Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis.
Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)
Read the detailed description
This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing.
Institutional Review Board-/Independent Ethics Committee approval must be granted before, The experimental intervention will be administered over 28-day cycles. Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies.
There must be adequate understanding of the indication for the requested use.
- Being tested
- Crenolanib besylate
- Keywords
- Compassionate use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crenolanib besylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FLT3-ITD MutationStudies 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
- Arog Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620318
- Sponsor's protocol ID
- ARO-EAP
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Mutations, PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 (FLT3) Mutations
- ClinicalTrials.gov ID
- NCT03620318
- Acronym / sponsor ID
- ARO-EAP
- Keywords
- Compassionate use
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Arog Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 8 Aug 2018 (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.
Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis.
Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)
Detailed description
This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing.
Institutional Review Board-/Independent Ethics Committee approval must be granted before, The experimental intervention will be administered over 28-day cycles. Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies.
There must be adequate understanding of the indication for the requested use.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options
- Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug
Key exclusion criteria (2 listed)
- Subject is eligible for enrollment in an ongoing clinical trial
- Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation
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 |
|---|---|---|
| Crenolanib besylate | 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 9 Aug 2024.
Related trials for FLT3-ITD Mutation
Not yet recruiting
MAC vs RIC for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD ( FLT3 - MAC vs RIC )
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Acute Myeloid Leukemia
Not yet recruitingPhase 2
Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Acute Myeloid Leukemia, Leukemia
Active, not recruitingPhase 3
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Leukemia
RecruitingPhase 1
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crenolanib besylate in people with FLT3-ITD Mutation and FLT3/TKD Mutation, run by Arog Pharmaceuticals, Inc. at 1 site in Italy.
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 2 inclusion and 2 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Vinay Jain, MD (214-593-0500, info@arogpharma.com), or a site near the patient. 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 9 Aug 2024.