NCT04655118 : A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible 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 trying to determine the effectiveness and dosing level of a targeted therapy drug (TL-895) 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 treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • 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, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

Commercial Sponsor

Telios Pharma, Inc.

Summary

This is a randomised trial with multiple experimental arms. Experimental Arm 1a (relapsed/refractory Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 2a (JAKi Intolerant Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 2b (JAKi Intolerant Myelofibrosis) participants will receive 300mg of TL-895 orally once daily (QD), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 3a (JAKi Ineligible Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 3b (JAKi Ineligible Myelofibrosis) participants will receive 300mg of TL-895 orally once daily (QD), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 1 Expansion (Relapsed/Refractory Myelofibrosis) participants will receive TL-895 orally at RP2D and schedule. Experimental Arm 2 Expansion (JAKi Intolerant Myelofibrosis) will receive TL-895 orally at RP2D and schedule. Experimental Arm 3 Expansion (JAKi Ineligible Myelofibrosis) will receive TL-895 orally at RP2D and schedule.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

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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