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

NCT04518345 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-02-06

No results posted yet for this study

Summary

This phase IB/II trial studies the best dose of TP-0903 and how well it works when given alone or with azacitidine in treating patients with FLT3 gene mutated acute myeloid leukemia. TP-0903 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TP-0903 alone or with azacitidine may kill more cancer cells.

Conditions

Interventions

DRUG

Azacitidine

Given IV

DRUG

Dubermatinib

Given PO

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY
  • Uma Borate

    lead OTHER

Principal Investigators

  • Uma Borate, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2021-10-13
Completion
2021-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518345 on ClinicalTrials.gov