Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)

NCT ID: NCT00479232

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-03-31

Brief Summary

This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.

Conditions

Leukemia, Myelocytic, Acute Myelodysplastic Syndromes; Myelodysplastic Syndromes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Vorinostat (sequential)

Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles. Up to 24 months of treatment.

Decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

decitabine

Intervention Type: DRUG

Cohort 2: Vorinostat (concurrent)

Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles.

Decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

decitabine

Intervention Type: DRUG

Interventions

vorinostat

Intervention Type: DRUG

decitabine

Intervention Type: DRUG

Other Intervention Names

MK-0683; SAHA; Dacogen

Eligibility Criteria

Inclusion Criteria

• Patient is at least 18 years old with refractory/relapsed AML

• If untreated AML, patient is older than 60 years old and not a candidate for standard 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 women 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; a mental or social condition that may interfere with patient following study procedures
• Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. Patient has a known history of hepatitis B or C infection
• Patient currently has another active cancer other than certain types of skin cancer
• Patient is heterosexual and able to have a child and is unwilling to practice birth control during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kirschbaum M, Gojo I, Goldberg SL, Bredeson C, Kujawski LA, Yang A, Marks P, Frankel P, Sun X, Tosolini A, Eid JE, Lubiniecki GM, Issa JP. A phase 1 clinical trial of vorinostat in combination with decitabine in patients with acute myeloid leukaemia or myelodysplastic syndrome. Br J Haematol. 2014 Oct;167(2):185-93. doi: 10.1111/bjh.13016. Epub 2014 Jul 8.

Reference Type: RESULT

PMID: 25040094 (View on PubMed)

Other Identifiers

2007_500

Identifier Type: -

Identifier Source: secondary_id

0683-055

Identifier Type: -

Identifier Source: org_study_id