Study of AR-67 (DB-67) in Myelodysplastic Syndrome (MDS)

NCT00956787 | Unknown Phase 2

• 2 other identifiers: ARN-AR67-IIS201MDACC PROTOCOL NO. 2008-0530
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if AR-67 is effective in the treatment for patients with MDS.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• To estimate the efficacy of AR-67 in treating patients with MDS who have failed prior therapies

  4 cycles (approximately 16 weeks)

Study Arms (1)

Treatment with AR-67

EXPERIMENTAL

Patients will receive AR-67 at an initial dose of 7.5 mg/m2 IV over 1 hour daily for 5 days.

Drug: AR-67 (20S)-7-t-Butyldimethylsilyl-10-hydroxycamptothecin)

Interventions

AR-67 (20S)-7-t-Butyldimethylsilyl-10-hydroxycamptothecin) DRUG

Patients will receive AR-67 at an initial dose of 7.5 mg/m2 IV over 1 hour daily for 5 days. In patients with stable disease, treatment may continue for up to a total of 12 courses of therapy; about 1 to 2 years.

Also known as: AR-67, (20S)-7-t-Butyldimethylsilyl-10-hydroxycamptothecin)

Treatment with AR-67

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with either of the following diagnoses:
• MDS and \>5% blasts, or IPSS risk group intermediate-1, intermediate-2 or high risk
• Chronic myelomonocytic leukemia (CMML)
• Patients must have failed prior therapy with either a hypomethylating agent (e.g., azacytidine, decitabine) alone or in combination with other agents. Patients with abnormalities in chromosome 5q, should have failed either a hypomethylating agent or lenalidomide.
• Patients intolerant or unable to receive these agents will be considered eligible.
• Age \> 18 years. Because no dosing or adverse event data are currently available on the use of AR-67 in patients \< 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
• ECOG performance status 0-2.
• Patients must have normal organ function as defined below:
• Total bilirubin: \< 1.5 x institutional upper limit of normal
• ALT (SGPT): \< 2.5 X institutional upper limit of normal
• Creatinine: \< 1.5 x institutional upper limit of normal
• The effects of AR-67 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential (i.e., not post-menopausal for at least 12 months and not surgically sterile) and men must agree to use effective methods of contraception. Women of childbearing potential (any women who is not surgically sterile or \> 2 years post menopause) must give consent for using a reliable method of contraception (e.g. double-barrier, tubal ligation or stable hormonal contraception) throughout the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients must have been off chemotherapy for 2 weeks prior to entering this study unless there is evidence of rapidly progressive disease. Patients must have recovered from the toxic effects of prior therapy to grade ≤1. The use of hydroxyurea is allowed to control counts up to 24 hrs prior to the start of therapy with AR-67.

You may not qualify if:

• Nursing or pregnant females or females who plan pregnancy during the duration of the study.
• Active and uncontrolled systemic infections.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Arno Therapeutics: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

7-tert-butyldimethylsilyl-10-hydroxycamptothecin

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jorge Cortes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Cortes, MD

CONTACT

(713) 794-5783; jcortes@mdanderson.org

Sheela Mathews, RN

CONTACT

713-792-1046; svmathew@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2009-08

Locations

US (1)