Recruiting
Phase 2

AR-67

Sponsor:

Arno Therapeutics

Code:

NCT00956787

Conditions

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT00956787

Start date

Jun, 2009

Status verified date

Aug, 2009

Completion date

Dec, 2014

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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)
2. 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.
3. 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.
4. ECOG performance status 0-2.
5. 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
6. 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.
7. Ability to understand and the willingness to sign a written informed consent document.
8. 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.

Exclusion Criteria:

1. Nursing or pregnant females or females who plan pregnancy during the duration of the study.
2. Active and uncontrolled systemic infections.
3. 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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with AR-67

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

Interventions

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

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.

Primary outcome measure

  • To estimate the efficacy of AR-67 in treating patients with MDS who have failed prior therapies [ Time Frame: 4 cycles (approximately 16 weeks) ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Jorge Cortes, MD

More Information

Sponsor

Arno Therapeutics

Last update posted

Jun 24, 2014

Last verified

Aug, 2009

Keywords

  • Myelodysplastic Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arno Therapeutics on 2014-06-24.