Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05037760 : A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMyelofibrosis

Trial Overview Read MoreRead more

This Phase II trial is evaluating how safe and effective a new drug (KER-050) is alone, and in combination with targeted therapy (ruxolitinib) in people with myelofibrosis.
 

This trial is treating patients with myelofibrosis.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

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

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

Scientific Title

A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

Commercial Sponsor

Keros Therapeutics

Summary

This is a non-randomised, open-label trial with four experimental arms. In experimental arm 1a (dose escalation), participants will receive KER-050 monotherapy, administered via subcutaneous injection (SC) every 4 weeks, for up to 13 cycles. In experimental arm 1b (dose escalation), participants will receive KER-050, administered SC, every 4 weeks, for up to 13 cycles, in combination with standard of care ruxolitinib, administered orally twice daily. In experimental arm 2a (dose expansion), participants will receive KER-050 monotherapy, administered SC, every 4 weeks, for up to 13 cycles. In experimental arm 2b, participants will receive KER-050, administered SC every 4 weeks for up to 13 cycles, in combination with standard of care ruxolitinib, administered orally twice daily.

Recruiting Hospitals Read MoreRead more

Ballarat Oncology & Haematology
Ballarat
Ms Rosemary Cotton
rosemaryc@ballaratoncology.com.au
03 5339 8000

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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