InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated:15 August 2023

Metorite: This study is evaluating how safe and effective chemotherapy (azacitidine) in combination with best supportive care, compared to placebo and best supportive care, is in people with low to intermediate IPSS-R myelodysplastic syndromeA Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Clinical summary

Summary

This study has two parts. The first part is seeking to determine the optimal dose of azacitidine. Eligible participants will be randomly allocated to receive oral azacitidine at one of two dose levels. The second part of this study is evaluating the effectiveness of azacitidine in addition to best supportive care, compared to placebo and best supportive care. Participants will be randomly allocated to receive either oral azacitidine plus best supportive care, or an oral placebo plus best supportive care.

Age

People18+

Phase

II/III

Trial Acronym

Metorite

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Commercial Sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Eligibility

Inclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You are able to swallow medication by mouth.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait