Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00590187 |
Recruitment Status :
Completed
First Posted : January 10, 2008
Last Update Posted : January 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia | Drug: sapacitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 408 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Actual Study Start Date : | December 2007 |
Actual Primary Completion Date : | December 1, 2018 |
Actual Study Completion Date : | December 1, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: A sapacitabine
200 mg b.i.d. x 7 days every 3-4 weeks
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Drug: sapacitabine
200 mg b.i.d. x 7 days every 3-4 weeks |
Experimental: B sapacitabine
300 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 |
Experimental: C sapacitabine
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
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Drug: sapacitabine
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks |
Experimental: D sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks
|
Drug: sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks |
Experimental: E sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks
|
Drug: sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks |
Experimental: F sapacitabine
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
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Drug: sapacitabine
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks |
Experimental: G sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks
|
Drug: sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks |
Experimental: H sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks
|
Drug: sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks |
Experimental: I sapacitabine
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
|
Drug: sapacitabine
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks |
- Survival [ Time Frame: one year ]
- Rate and duration of complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety [ Time Frame: during study ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590187
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 |
Study Chair: | Hagop M Kantarjian, MD | M.D. Anderson Cancer Center |
Publications of Results:
Responsible Party: | Cyclacel Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00590187 |
Other Study ID Numbers: |
CYC682-06 |
First Posted: | January 10, 2008 Key Record Dates |
Last Update Posted: | January 25, 2019 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type |
Neoplasms Sapacitabine Antineoplastic Agents |