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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Delta-Fly Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Delta-Fly Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01702155
First received: October 3, 2012
Last updated: January 30, 2014
Last verified: January 2014
  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).


Condition Intervention Phase
Acute Myeloid Leukemia
Acute Lymphocytic Leukemia
Drug: DFP-10917
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of DFP 10917 Given by Continuous Infusion in Patients With Relapsed or Refractory Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Delta-Fly Pharma, Inc.:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Up to 30 days after the last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 2/3 the cumulative 7-day MTD
Drug: DFP-10917

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702155

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Hagop M Kantarjian, MD    713-792-7026    hkantarjian@mdanderson.org   
Principal Investigator: Hagop Kantarjian, MD         
Sponsors and Collaborators
Delta-Fly Pharma, Inc.
  More Information

No publications provided

Responsible Party: Delta-Fly Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01702155     History of Changes
Other Study ID Numbers: D11-11002
Study First Received: October 3, 2012
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Isoflurophate
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014