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Nucleoside Metabolic Inhibitor

Vorinostat + Azacitidine for Myelodysplastic Syndrome / Acute Myeloid Leukemia

Q: What medical conditions is Vorinostat commonly administered for?

Vorinostat has been clinically proven to successfully treat induction chemotherapy, refractory anemias, and acute myelocytic leukemias.

Q: How many subjects are being monitored for this research endeavor?

At the present time, this clinical trial is not taking on any new patients. The listing was first published back in November 2006 and updated as recently as September 2022. Currently, 2758 trials are seeking participants with myelodysplastic syndromes and 202 studies require volunteers for Vorinostat treatments.

Q: How many locations are presently facilitating this experiment?

This clinical trial is running in 7 distinct sites, including Chicago, Baltimore and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>. Patients are encouraged to pick the centre located nearest them as this will reduce their travelling needs if they take part.

Q: Are there still vacancies available to partake in this research?

Based on the data posted to clinicaltrials.gov, this research undertaking is no longer recruiting patients; however, it was initially made public on November 22nd 2006 and most recently updated in September of 2022. Conversely, there are presently 2960 other trials actively looking for enrollees.

Q: Has research in Vorinostat already been conducted prior to this investigation?

At this time, 34 Vorinostat trials are in Phase 3 with 202 total clinical studies taking place. Although the majority of these experiments take place out of Saint Louis, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>, there is a global reach as 6157 sites across the world have begun to run investigations into Vorinostat's efficacy.

Phase 1 & 2

Waitlist Available

Led By Lewis R Silverman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Additional criteria for AML patients include stable disease, no recent use of corticosteroids, interferon, retinoids, hematopoietic growth factors, azacitidine, decitabine, vorinostat, or investigational agents

Patients must have a diagnosis of either MDS according to FAB and IPSS criteria, or a diagnosis of AML according to FAB or WHO criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month post-treatment

Awards & highlights

Study Summary

This trial is studying vorinostat and azacitidine to treat patients with myelodysplastic syndromes or acute myeloid leukemia.

Who is the study for?

This trial is for adults with certain types of blood disorders, including various forms of leukemia and myelodysplastic syndromes. Participants should have specific disease characteristics, not be on certain medications recently, and must have a life expectancy over 2 months. They need to be in relatively good health otherwise (ECOG <=2), with normal organ function tests. Pregnant women or those who've had recent cancer treatments are excluded.Check my eligibility

What is being tested?

The study is testing the combination of two drugs: Vorinostat and Azacitidine. It aims to find the safest doses and see how effective they are against different blood disorders like acute myeloid leukemia and myelodysplastic syndromes by blocking enzymes that allow abnormal cells to grow or by directly killing them.See study design

What are the potential side effects?

Potential side effects include allergic reactions similar to other compounds related to Vorinostat or Azacitidine, as well as risks associated with chemotherapy such as fatigue, nausea, infection risk increase due to low white blood cell counts, bleeding from low platelets, liver issues indicated by elevated bilirubin levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have AML and haven't used certain medications recently.

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I have been diagnosed with MDS or AML according to specific medical criteria.

Select...

My AML is new or evolved from MDS and is not likely to respond well to treatment.

Select...

I have a type of anemia related to my bone marrow disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Distribution of toxicities in the 12th treatment arm (Phase II)

Incidence of toxicities of vorinostat in combination with azacitidine graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 (Phase I)

Objective overall response proportion (complete response [CR] + CR with incomplete blood count + partial response) (Phase II)

Secondary outcome measures

Frequency of leukemic transformation

Overall survival

Progression-free survival

+2 more

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102

57%

Nausea

47%

Fatigue

43%

Diarrhoea

40%

Decreased appetite

40%

Vomiting

29%

Dyspnoea

24%

Constipation

20%

Weight decreased

18%

Tumour pain

18%

Cough

15%

Pleural mesothelioma malignant advanced

14%

Anaemia

12%

Pyrexia

Insomnia

Dry mouth

Blood creatinine increased

Abdominal pain

Back pain

Dysgeusia

Dizziness

Oedema peripheral

Thrombocytopenia

Headache

C-reactive protein increased

Dehydration

Musculoskeletal pain

Malaise

Pneumonia

Anxiety

Rash

Atrial fibrillation

Accidental overdose

Pleural effusion

Sepsis

Overdose

Bladder cancer

Pneumothorax

Non-cardiac chest pain

Confusional state

General physical health deterioration

Pericarditis

Disseminated intravascular coagulation

Death

Ascites

Dysphagia

Pulmonary embolism

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Vorinostat

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (azacitidine, vorinostat)Experimental Treatment4 Interventions

Patients receive azacitidine SC QD on days 1-7 and vorinostat PO 2-3 times daily on days 3-5, 3-9, or 3-16. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorinostat

2014

Completed Phase 3

~1600

Azacitidine

2012

Completed Phase 3

~1440

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,018 Total Patients Enrolled

Lewis R SilvermanPrincipal InvestigatorMontefiore Medical Center - Moses Campus

Media Library

Azacitidine (Nucleoside Metabolic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00392353 — Phase 1 & 2

Megakaryoblastic Leukemia Research Study Groups: Treatment (azacitidine, vorinostat)

Megakaryoblastic Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT00392353 — Phase 1 & 2

Azacitidine (Nucleoside Metabolic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00392353 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is Vorinostat commonly administered for?

"Vorinostat has been clinically proven to successfully treat induction chemotherapy, refractory anemias, and acute myelocytic leukemias."

Answered by AI

How many subjects are being monitored for this research endeavor?

"At the present time, this clinical trial is not taking on any new patients. The listing was first published back in November 2006 and updated as recently as September 2022. Currently, 2758 trials are seeking participants with myelodysplastic syndromes and 202 studies require volunteers for Vorinostat treatments."

Answered by AI

How many locations are presently facilitating this experiment?

"This clinical trial is running in 7 distinct sites, including Chicago, Baltimore and New york. Patients are encouraged to pick the centre located nearest them as this will reduce their travelling needs if they take part."

Answered by AI

Are there still vacancies available to partake in this research?

"Based on the data posted to clinicaltrials.gov, this research undertaking is no longer recruiting patients; however, it was initially made public on November 22nd 2006 and most recently updated in September of 2022. Conversely, there are presently 2960 other trials actively looking for enrollees."

Answered by AI

Has research in Vorinostat already been conducted prior to this investigation?

"At this time, 34 Vorinostat trials are in Phase 3 with 202 total clinical studies taking place. Although the majority of these experiments take place out of Saint Louis, Missouri, there is a global reach as 6157 sites across the world have begun to run investigations into Vorinostat's efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia

2006. "Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00392353.

All > Acute Myeloid Leukemia > Aml