Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes, Myelodysplastic Syndromes

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events

Outcome Description:

Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.

Outcome Time Frame:

Day 1 to 28 of Cycle 1

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

March 2012

Related Keywords:

  • Leukemia, Myelocytic, Acute Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Leukemia
  • Myelocytic
  • Acute Myelodysplastic Syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia