Phase I/II Study of DFP-10917 in Patients With Acute Leukemia

October 23, 2019 updated by: Delta-Fly Pharma, Inc.

A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia

The purpose of this study is to determine the safety and efficacy of DFP-10917 given via continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will determine the safety and efficacy of DFP-10917 in patients with AML or ALL. The Phase I dose-escalation portion of the study will determine the highest tolerable dose and regimen (7 or 14 day continuous infusion) based on safety data in patients with refractory or relapsed AML or ALL. The phase II portion will investigate the safety and efficacy of DFP-10917, at the dose and regimen to be determined in the Phase I portion, in patients with refractory or relapsed AML.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must have pathologically-confirmed acute leukemia, refractory or relapsed after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available Phase II Only: Patient must have histologically or pathologically confirmed diagnosis of AML based on WHO classification that is refractory after standard therapy, or for which conventional systemic chemotherapy is not reliably effective, or no effective therapy is available. Patients aged 60 years or older with newly diagnosed AML who are not eligible for, or who refuse, standard care are also eligible.
  2. Aged ≥ 18 years.
  3. ECOG Performance Status of 0, 1 or 2.
  4. Adequate clinical laboratory values (i.e., plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution, bilirubin <=1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 x ULN).
  5. Absence of CNS involvement by leukemia.
  6. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
  7. Signed informed consent prior to the start of any study specific procedures.
  8. Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.

Exclusion Criteria:

  1. The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
  2. Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
  3. Extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
  4. Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
  5. A pregnant or lactating woman.
  6. Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
  7. Patient has acute promyelocytic leukemia (APL).
  8. Patients with known HIV, HBV or HCV infection (note: testing for these infections is not required).
  9. Documented or known clinically significant bleeding disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DFP-10917
  1. 7-day continuous infusion (in the vein): Starting dose 4 mg/m^2
  2. 14-day continuous infusion (in the vein): Starting dose 10 mg/m^2
  3. Phase II Only: 6 mg/m^2 for the 14-day continuous infusion (in the vein)
Drug: DFP-10917

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: Up to 30 days after the last dose
Up to 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delta-Fly Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2012

Primary Completion (ACTUAL)

January 18, 2017

Study Completion (ACTUAL)

October 11, 2017

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (ESTIMATE)

October 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D11-11002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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