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Nucleoside Analog

Dubermatinib for Acute Myeloid Leukemia

Q: What are some similar studies that have used Dubermatinib in the past?

33 Dubermatinib trials are currently in Phase 3 with 180 trials active in total. Most of these studies taking place in Saint Louis, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>; however, there are 5727 clinical trial sites for Dubermatinib globally.

Q: Are people currently signing up to be a part of this experiment?

This clinical trial, which was first advertised on November 5th 2020, is still seeking participants according to the latest update on January 4th 2022.

Q: How many patients are a part of this clinical research?

That is correct. The listing on clinicaltrials.gov says that the trial is still looking for patients. It was first posted on November 5th, 2020 and was last updated on January 4th, 2022. They are aiming to have 80 people total at 1 location.

Q: What goals is this clinical trial hoping to achieve?

The primary outcome of this study will be the Composite CR rate with partial hematologic recovery (CRh) rate, which will be monitored for up to 5 years post-registration. Secondary outcomes include The Number of patients who proceed to <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a>, Incidence of treatment-related adverse events, and Overall survival.

Q: What are the main purposes that Dubermatinib is typically used for?

Dubermatinib is most often used as a treatment for <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>. Additionally, it can be prescribed to patients struggling with 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia.

Phase < 1

Waitlist Available

Led By Uma Borate, MD

Research Sponsored by Bhavana Bhatnagar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post registration

Awards & highlights

Study Summary

This trial is studying the best dose of TP-0903 and whether it is more effective when given with azacitidine to treat patients with FLT3 gene mutated acute myeloid leukemia.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite CR rate with partial hematologic recovery (CRh) rate

Composite complete response (CR) rate

Maximum tolerated dose of dubermatinib (TP-0903)

Secondary outcome measures

Disease-free survival

Incidence of treatment-related adverse events

Maximum grade of each type of adverse event

+3 more

Other outcome measures

Area under the plasma concentration (AUC) pharmacokinetics (PK)

Changes in cytokines/chemokines

Effect of TP-0903 on inhibition of phospho-protein expression Effect of TP-0903 on inhibition of phospho-protein expression Effect of TP-0903 on inhibition of phospho-protein expression Impact of TP-0903 on kinase signaling

+2 more

Side effects data

From 2023 Phase 1 trial • 48 Patients • NCT02038777

67%

Pyrexia

67%

Pneumonia

33%

Enteritis infectious

33%

Hyperaesthesia teeth

33%

Nausea

33%

Infective tenosynovitis

33%

Bronchitis

33%

Bacteraemia

33%

Rhinitis

33%

Blood creatine phosphokinase increased

33%

Prothrombin time prolonged

33%

Dysgeusia

33%

Muscle spasms

33%

Auricular chondritis

33%

Small intestinal haemorrhage

33%

Malaise

33%

Oedema

33%

Influenza

33%

Nasopharyngitis

33%

Phlebitis

100%

80%

60%

40%

20%

Study treatment Arm

Monotherapy Cohort: PF-04449913 25 mg

Monotherapy Cohort: PF-04449913 50 mg

Monotherapy Cohort: PF-04449913 100 mg

Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg

Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin

Combination Cohort 3: PF-04449913 100 mg + Azacitidine

Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg

Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dubermatinib)Experimental Treatment2 Interventions

FLT3 AML WITH RELAPSED/REFRACTORY DISEASE: INDUCTION: Patients receive dubermatinib PO QD on days 1-21. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients with clinical or hematologic response and not transplant eligible may continue dubermatinib until loss of response/clinical benefit. Patients with clinical or hematologic response and transplant eligible may continue dubermatinib until one week prior to admission.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Dubermatinib

2020

Completed Early Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bhavana BhatnagarLead Sponsor

3 Previous Clinical Trials

61 Total Patients Enrolled

Sumitomo Pharma America, Inc.Industry Sponsor

237 Previous Clinical Trials

52,729 Total Patients Enrolled

Uma BorateLead Sponsor

5 Previous Clinical Trials

242 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some similar studies that have used Dubermatinib in the past?

"33 Dubermatinib trials are currently in Phase 3 with 180 trials active in total. Most of these studies taking place in Saint Louis, Missouri; however, there are 5727 clinical trial sites for Dubermatinib globally."

Answered by AI

Are people currently signing up to be a part of this experiment?

"This clinical trial, which was first advertised on November 5th 2020, is still seeking participants according to the latest update on January 4th 2022."

Answered by AI

How many patients are a part of this clinical research?

"That is correct. The listing on clinicaltrials.gov says that the trial is still looking for patients. It was first posted on November 5th, 2020 and was last updated on January 4th, 2022. They are aiming to have 80 people total at 1 location."

Answered by AI

What goals is this clinical trial hoping to achieve?

"The primary outcome of this study will be the Composite CR rate with partial hematologic recovery (CRh) rate, which will be monitored for up to 5 years post-registration. Secondary outcomes include The Number of patients who proceed to transplant, Incidence of treatment-related adverse events, and Overall survival."

Answered by AI

What are the main purposes that Dubermatinib is typically used for?

"Dubermatinib is most often used as a treatment for cancer. Additionally, it can be prescribed to patients struggling with 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia

Uma Borate 2020. "TP-0903 for the Treatment of FLT3 Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04518345.