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Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00590187
First received: December 23, 2007
Last updated: November 7, 2011
Last verified: November 2011
  Purpose
The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: sapacitabine
Drug: Sapacitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate and duration of complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety [ Time Frame: during study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: sapacitabine
200 mg b.i.d. x 7 days every 3-4 weeks
Experimental: B Drug: sapacitabine
300 mg b.i.d. x 7 days every 3 - 4 weeks
Experimental: C Drug: sapacitabine
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Experimental: Arm D Drug: sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks
Experimental: Arm E Drug: sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks
Experimental: Arm F Drug: sapacitabine
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Experimental: Arm G Drug: sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks
Experimental: Arm H Drug: Sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks
Experimental: Arm I Drug: sapacitabine
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
  • Age 70 years or older for AML and 60 years or older for MDS
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)
  • Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)
  • Life expectancy reasonably adequate for evaluating the treatment effect
  • Patient must be able to swallow capsules
  • Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
  • All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
  • Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • AML is of the sub-type of acute promyelocytic leukemia
  • Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS
  • Patients with known central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study
  • Known to be HIV-positive
  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: NCT00590187

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCLA Division of Hematology-Oncology
Los Angeles, California, United States, 90095
Stanford Hospitals and Clinics
Stanford, California, United States, 94305
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institiute
Buffalo, New York, United States, 14263
New York Medical College
Hawthorne, New York, United States, 10532
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt U Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Study Director: Judy H. Chiao, M.D. Cyclacel Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00590187     History of Changes
Other Study ID Numbers: CYC682-06 
Study First Received: December 23, 2007
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on December 08, 2016