Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
This study is currently recruiting participants.
Verified November 2011 by Cyclacel Pharmaceuticals, Inc.
Sponsor:
Cyclacel Pharmaceuticals, Inc.
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
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590187
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Amy Valdmanis 205-975-9481 | |
| Principal Investigator: James Foran, M.D. | |
| United States, California | |
| UCLA Division of Hematology-Oncology | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Rose Malone 310-794-0242 | |
| Principal Investigator: Gary Schiller, M.D. | |
| Stanford Hospitals and Clinics | Completed |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Nowalk Hospital | Withdrawn |
| Norwalk, Connecticut, United States, 06856 | |
| United States, Georgia | |
| Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Christine Hergert 404-778-1822 | |
| Principal Investigator: Martha Arellano, M.D. | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Margaret Green, RN 773-702-0267 | |
| Principal Investigator: Wendy Stock, M.D. | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Jodi Palonis 312-942-3327 | |
| Principal Investigator: Parameswaran Venugopal, M.D. | |
| Northwestern University Feinberg School of Medicine | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Mary Beth Riley 312-695-1379 | |
| Principal Investigator: Jessica Altman, M.D. | |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Rose Solberg, RN 402-559-4810 | |
| Principal Investigator: Lori Maness, M.D. | |
| United States, New Jersey | |
| The Cancer Center at Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Sora Limor 201-336-8598 | |
| Principal Investigator: Stuart Goldberg, M.D. | |
| United States, New York | |
| Roswell Park Cancer Institiute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Laurie Forde, RN 716-845-8360 | |
| Principal Investigator: Meir Wetzler, M.D. | |
| New York Medical College | Recruiting |
| Hawthorne, New York, United States, 10532 | |
| Contact: Muhammad Rasul 914-594-4400 ext 110 | |
| Principal Investigator: Karen Seiter, M.D. | |
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Tara Nisbet 717-531-0003 ext 285453 | |
| Principal Investigator: David Claxton, M.D. | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Melissa Potuzak 215-662-7383 | |
| Principal Investigator: Selina Luger, M.D. | |
| United States, Tennessee | |
| Vanderbilt U Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Violeta Vartic 615-343-1467 | |
| Principal Investigator: Madan Jagasia, M.D. | |
| United States, Texas | |
| The University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Patricia Boone, RN 713-792-9191 | |
| Principal Investigator: Hagop Kantarjian, M.D. | |
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
| Study Director: | Judy H. Chiao, M.D. | Cyclacel Pharmaceuticals, Inc. |
More Information
No publications provided by Cyclacel Pharmaceuticals, Inc.
Additional 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, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on May 16, 2013