Clinical Trials /

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

NCT01702155

Description:

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Unknown status

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase I/II Study of DFP-10917 in Patients With Acute Leukemia
  • Official Title: A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia

Clinical Trial IDs

  • ORG STUDY ID: D11-11002
  • NCT ID: NCT01702155

Conditions

  • Acute Myeloid Leukemia
  • Acute Lymphocytic Leukemia

Interventions

DrugSynonymsArms
DFP-10917DFP-10917

Purpose

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).

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.
    

Trial Arms

NameTypeDescriptionInterventions
DFP-10917Experimental7-day continuous infusion (in the vein): Starting dose 4 mg/m^2 14-day continuous infusion (in the vein): Starting dose 10 mg/m^2 Phase II Only: 6 mg/m^2 for the 14-day continuous infusion (in the vein)
  • DFP-10917

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Delta-Fly Pharma, Inc.

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