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Dose-Escalation Study of Ponatinib, a FLT3 Inhibitor, With and Without Combination of 5-Azacytidine, in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML)

NCT02829840 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-06-02

No results posted yet for this study

Summary

The goal of Part 1 of this clinical research study is to learn if ponatinib alone can help to control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this drug will also be studied.

The goal of Part 2 of this clinical research study is to find the highest tolerable dose of ponatinib in combination with 5-azacytidine and to learn if the highest dose level found can help to control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this combination will also be studied.

Conditions

  • Leukemia
  • FLT3-Mutated Acute Myeloid Leukemia
  • FLT3-Mutated High-Risk Myelodysplastic Syndrome

Interventions

DRUG

Ponatinib

Part 1: Ponatinib at starting dose of 30 mg by mouth every day for one 28 day cycle. Part 2 Phase I Dose Escalation: Ponatinib at starting dose of 30 mg by mouth every day of a 28 day cycle. Part 2 Phase II Dose Expansion: Ponatinib at maximum tolerated dose from Phase I by mouth every day of a 28 day cycle.

DRUG

5-azacytidine

Part 2 Phase I Dose Escalation: 5-azacytidine at dose of 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) for on Days 1-7 of every 28 day cycle. Part 2 Phase II Dose Expansion: 5-azacytidine 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) on Days 1-7 of every 28 day cycle.

BEHAVIORAL

Phone Calls

About 30 days after end-of-study visit, study staff calls participant and asks if they have had any side effects and/or started any new treatment(s). If disease appears to be responding to study drugs, study staff calls participant every 3-6 months for up to 5 years and asks how they are doing and about any side effects they may be having.

Sponsors & Collaborators

  • Ariad Pharmaceuticals

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naval Daver, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-09-30

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Entities

Diseases

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 NCT02829840 on ClinicalTrials.gov