Trial record 1 of 1 for:    NCT00590187
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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 because the information has not been verified recently.
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

December 23, 2007
November 7, 2011
December 2007
November 2011   (final data collection date for primary outcome measure)
Survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00590187 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: sapacitabine
    200 mg b.i.d. x 7 days every 3-4 weeks
  • Drug: sapacitabine
    300 mg b.i.d. x 7 days every 3 - 4 weeks
  • Drug: sapacitabine
    400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
  • Drug: sapacitabine
    200 mg b.i.d. x 7 consecutive days every 4 weeks
  • Drug: sapacitabine
    300 mg q.d. x 7 consecutive days every 4 weeks
  • Drug: sapacitabine
    300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
  • Drug: Sapacitabine
    300 mg q.d. x 7 consecutive days every 4 weeks
  • Drug: sapacitabine
    100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
  • Experimental: A
    Intervention: Drug: sapacitabine
  • Experimental: B
    Intervention: Drug: sapacitabine
  • Experimental: C
    Intervention: Drug: sapacitabine
  • Experimental: Arm D
    Intervention: Drug: sapacitabine
  • Experimental: Arm E
    Intervention: Drug: sapacitabine
  • Experimental: Arm F
    Intervention: Drug: sapacitabine
  • Experimental: Arm G
    Intervention: Drug: sapacitabine
  • Experimental: Arm H
    Intervention: Drug: Sapacitabine
  • Experimental: Arm I
    Intervention: Drug: sapacitabine
Kantarjian H, Faderl S, Garcia-Manero G, Luger S, Venugopal P, Maness L, Wetzler M, Coutre S, Stock W, Claxton D, Goldberg SL, Arellano M, Strickland SA, Seiter K, Schiller G, Jabbour E, Chiao J, Plunkett W. Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. Lancet Oncol. 2012 Nov;13(11):1096-104. doi: 10.1016/S1470-2045(12)70436-9. Epub 2012 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
November 2011   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Not Provided
United States
 
NCT00590187
CYC682-06
No
Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Not Provided
Study Director: Judy H. Chiao, M.D. Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP