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Closed (no longer recruiting)Last updated: 23 October 2023

This phase II trial is trying to determine the effectiveness and dosing level of a targeted therapy drug (TL-895) in people with MyelofibrosisA 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

Clinical summary

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.

Conditions

This trial is treating patients with Myelofibrosis.

Cancer

Blood Cancers Blood

Age

People18+

Phase

II

More information

Trial Identifiers

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Commercial Sponsor

Telios Pharma, Inc.

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

Eligibility

Inclusion

  • 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.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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