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A Study of Oral Clofarabine in Adult Patients With Myelodysplastic Syndromes (MDS)

This study has been terminated.
(Terminated to focus on comparable trial, CLOMDS02507)
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00750334
First received: September 9, 2008
Last updated: July 29, 2009
Last verified: March 2009
  Purpose

This study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: clofarabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Finding and Food Effect Study of Oral Clofarabine in Previously Treated Adult Patients With Myelodysplastic Syndromes (MDS)

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Maximum Tolerated dose levels [ Time Frame: First Cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK profile [ Time Frame: After MTD is established ] [ Designated as safety issue: No ]
  • Food effect on profile [ Time Frame: After MTD is established ] [ Designated as safety issue: No ]
  • Activity of clofarabine in this dosing regimen [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A
clofarabine Dose Escalation
Drug: clofarabine
Drug given Daily x 14 days and 7 days of rest for 21 day cycle
Experimental: Part B
Part B is an open-label, replicated cross-over study in which 12 additional patients will be enrolled and treated at the MTD determined in part A to evaluate the effect of food on the PK disposition of oral clofarabine.
Drug: clofarabine
Drug given Daily X 14 days and 7 days of rest for 21 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed, written informed consent.
  • Be at least 18 years old.
  • Have a pathologically confirmed MDS and score according to the IPSS at study entry. Pathologic confirmation is the responsibility of the investigator.
  • Have been treated previously for MDS as follow: a.Patients must have had at least 1, but no more than 2, prior treatment regimens; b.Patients must not have refractory (i.e., disease progression or no evidence of response while on treatment) to more than 1 prior treatment regimen.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Be able to comply with study procedures and follow-up examinations.
  • Have adequate hepatic and renal function.
  • Be non-fertile or agree to use birth control during the study through the end of the last treatment visit and at least 90 days after.

Exclusion Criteria:

  • Have had a readjustment of dose and/or schedule of erythropoietin, granulocyte colony stimulating factor(G-CSF) or other growth factors within 8 weeks prior to the first dose of oral clofarabine.
  • Have had any other chemotherapy or any investigational therapy for MDS within 4 weeks of the first dose of oral clofarabine.
  • Have not recovered to ≤ Grade 2 in severity of any drug-related non-hematologic toxicity prior to the first dose of oral clofarabine.
  • Have an uncontrolled systemic fungal, bacterial, viral or other infection. Have a history of serious disease involving the heart.
  • Have a clinically significant cardiac assessment at screening or a known family history QT prolongation.
  • Currently uses a medication known to prolong the QT interval.
  • Have had any prior treatment with clofarabine (IV or oral).
  • Have had a diagnosis of another malignancy, unless the patient has been disease free for at least 3 years after completing curative intent therapy except for the following: a. Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment or the condition has been completed. b. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
  • Have prior positive test for the human immunodeficiency virus (HIV).
  • Have gastrointestinal disease or prior surgery, which may affect the ability of the patient to absorb oral clofarabine.
  • Is currently participating in another concurrent investigational protocol that is not restricted to data and/or sample collection for patient demographic and/or disease purposes.
  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: NCT00750334

Locations
United States, Florida
Malignant Hematology Administration, H. Lee Moffitt Cancer Center
Tampa, Florida, United States
United States, Minnesota
Division of Hematology Mayo Clinic
Rochester, Minnesota, United States
United States, Texas
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00750334     History of Changes
Other Study ID Numbers: CLOMDS01206
Study First Received: September 9, 2008
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Oral Clofarabine,
relapsed/refractory MDS,
Myelodysplastic

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Clofarabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014