Phase I Trial of Vorinostat (MK0683, SAHA) in Combination With Decitabine in Patients With AML or MDS

Condition(s) targeted: Leukemia, Myelocytic; Myelodysplastic Syndromes

Intervention: vorinostat (Drug); decitabine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine. Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) are eligible.

Official title: A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the safety and tolerability of this treatment combination.

Secondary outcome: To determine the efficacy of this combination

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is at least 18 years old

- Patient has an established diagnosis of one of the following:

1. Intermediate-high risk MDS

2. Refractory or relapsed AML

3. Untreated AML (if patient is not a candidate for standard cytotoxic chemotherapy)

- Patient is at least 4 weeks from prior treatment and has recovered from all prior

treatment side effects

- Patient has no known liver or kidney problems

- Patient knows of no reason they can not receive transfusions of blood clotting cells

(platelets)

- Patient is able to swallow capsules

- Patients both male and female are willing to practice birth control during the study

Exclusion Criteria:

- Patient has received prior treatment with valproic acid, decitabine or azacitidine

- Being is less than 18 years of age or if patient has untreated AML is below 60 years

of age

- Patient is a female who is pregnant or breastfeeding

- Patient has an active infection that requires antibiotics

- Patient has uncontrolled illness including but not limited to the following: heart

problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas

- Patient has a mental or social condition that may interfere with patient following

study procedures

- Patient has known HIV infection or HIV-related malignancy

- Patient has a known history of hepatitis B or C infection

- Patient has a known allergy or hypersensitivity to any component of vorinostat or

decitabine

- Patient currently has another active cancer other than certain types of skin cancer

Toll Free Number, Phone: 1-888-577-8839

Call for Information, Los Angeles, California 90033, United States; Recruiting

Call for Information, Duarte, California 91010, United States; Recruiting

Call for Information, New Haven, Connecticut 06520-0000, United States; Recruiting

Call for Information, Maywood, Illinois 60153, United States; Recruiting

Call for Information, Baltimore, Maryland 21201-0000, United States; Recruiting

Call for Information, Ann Arbor, Michigan 48109, United States; Recruiting

Call for Information, Hackensack, New Jersey 07601, United States; Recruiting

Call for Information, New York, New York 10021-6007, United States; Recruiting

Call for Information, New York, New York 10011, United States; Recruiting

Call for Information, Winston-Salem, North Carolina 27157, United States; Recruiting

Call for Information, Houston, Texas 77030-4009, United States; Recruiting

Call for Information, Milwaukee, Wisconsin 53226, United States; Recruiting

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: May 2007
Last updated: August 6, 2008