Decitabine Versus Supportive Care in Adults With Advanced-stage MDS
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| ClinicalTrials.gov Identifier: NCT00043381 |
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Recruitment Status :
Completed
First Posted : August 12, 2002
Last Update Posted : January 24, 2013
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Sponsor:
Astex Pharmaceuticals, Inc.
Information provided by:
Astex Pharmaceuticals, Inc.
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Brief Summary:
To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myelodysplastic Syndrome | Drug: decitabine (5-aza-2'deoxycytidine) | Phase 3 |
This experimental (investigational) study is intended to answer the question of whether decitabine is any better than supportive care alone in delaying progression (worsening) of the disease, prolonging survival or improving the overall quality of life for MDS patients who are not candidates for bone marrow transplant (BMT).
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome |
| Study Start Date : | April 2001 |
| Actual Primary Completion Date : | November 2002 |
| Actual Study Completion Date : | April 2003 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Myelodysplastic Syndromes
Drug Information available for:
Decitabine
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion:
- MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3, AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization
- 18 years or older
- Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding
- ECOG or WHO performance status of 0-2
- Written informed consent
- Normal renal and hepatic function (creatinine </= 2 mg/dL, bilirubin </= 1.5 mg/dL, SGPT </= 2 times the upper limit of normal range)
Exclusion:
- Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive malignant disease
- Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)
- Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.
- Administration of any investigational agent within the 30 days preceding study initiation.
- Uncontrolled cardiac disease or congestive heart failure
- Uncontrolled restrictive or obstructive pulmonary disease
- Active viral or bacterial infection
- Superimposed autoimmune hemolytic anemia or thrombocytopenia
- Known positive serology for HIV
- Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.
Information from the National Library of Medicine
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): NCT00043381
Locations
Show 24 study locations
Sponsors and Collaborators
Astex Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David S. Smith, Vice President-Regulatory and Quality Assurance, SuperGen, Inc. |
| ClinicalTrials.gov Identifier: | NCT00043381 |
| Obsolete Identifiers: | NCT00022061 |
| Other Study ID Numbers: |
D-0007 |
| First Posted: | August 12, 2002 Key Record Dates |
| Last Update Posted: | January 24, 2013 |
| Last Verified: | June 2011 |
Keywords provided by Astex Pharmaceuticals, Inc.:
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myelodysplastic syndrome MDS chronic myelomonocytic leukemia |
CMML decitabine 5-aza-2'deoxycytidine |
Additional relevant MeSH terms:
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Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Neoplasms Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |