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

Myelodysplastic Syndromes Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00750334
• Other study ID #: CLOMDS01206
• Status: Terminated
• Phase: Phase 1
• First received: September 9, 2008
• Last updated: May 19, 2015
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• clofarabine
Drug given Daily x 14 days and 7 days of rest for 21 day cycle
• clofarabine
Drug given Daily X 14 days and 7 days of rest for 21 day cycle

Locations

Country	Name	City	State
United States	Division of Hematology Mayo Clinic	Rochester	Minnesota
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Malignant Hematology Administration, H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated dose levels		First Cycle	Yes
Secondary	PK profile		After MTD is established	No
Secondary	Food effect on profile		After MTD is established	No
Secondary	Activity of clofarabine in this dosing regimen		Duration of Study	No