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Nucleoside Analog

Dubermatinib for Acute Myeloid Leukemia

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
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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
100%
Leukopenia
100%
Thrombocytopenia
83%
Dysgeusia
83%
Neutropenia
67%
Anaemia
67%
Febrile neutropenia
67%
Nausea
67%
Decreased appetite
50%
Pyrexia
50%
Rash
50%
Vomiting
50%
Weight decreased
50%
Hypokalaemia
50%
Hypophosphataemia
50%
Alopecia
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Blood creatinine increased
33%
Constipation
33%
Malaise
33%
Hypoalbuminaemia
33%
Stomatitis
33%
Hyperkalaemia
33%
Hypomagnesaemia
33%
Hyponatraemia
33%
Insomnia
17%
Dry skin
17%
Periodontitis
17%
Erythema nodosum
17%
Pain in extremity
17%
Fibrin D dimer increased
17%
Delirium
17%
Disseminated intravascular coagulation
17%
Gingival bleeding
17%
Oedema peripheral
17%
Hepatic function abnormal
17%
Blood alkaline phosphatase increased
17%
Hypercalcaemia
17%
Hypocalcaemia
17%
Back pain
17%
Acute lung injury
17%
Pneumothorax
17%
Contusion
17%
Blood bilirubin increased
17%
Pneumonia bacterial
17%
Pneumonia cytomegaloviral
17%
Interstitial lung disease
17%
Dermatitis exfoliative generalised
17%
Lymphopenia
17%
Cardiac failure congestive
17%
Diarrhoea
17%
Catheter site pain
17%
Facial bones fracture
17%
Fall
17%
Blood creatine phosphokinase increased
17%
Electrocardiogram QT prolonged
17%
Fibrin degradation products increased
17%
Arthralgia
17%
Muscle spasms
17%
Tendonitis
17%
Headache
17%
Glycosuria
17%
Haematuria
17%
Proteinuria
17%
Oropharyngeal pain
17%
Pneumonitis
17%
Rash maculo-papular
17%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin
Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg
Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg
Monotherapy Cohort: PF-04449913 25 mg
Monotherapy Cohort: PF-04449913 100 mg
Monotherapy Cohort: PF-04449913 50 mg
Combination Cohort 3: PF-04449913 100 mg + Azacitidine
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

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Industry Sponsor
236 Previous Clinical Trials
52,789 Total Patients Enrolled
Bhavana BhatnagarLead Sponsor
3 Previous Clinical Trials
61 Total Patients Enrolled
Uma BorateLead Sponsor
5 Previous Clinical Trials
258 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
~1 spots leftby Mar 2025