Chronic Myeloid Leukemia Accelerated Phase (CML-AP, Ph+) Clinical Trial
Official title:
A Phase 1A Dose Escalation and Phase 1B Expansion Study to Evaluate the Safety and Tolerability of ETC-1907206 in Combination With Dasatinib in Advanced Haematologic Malignancies
This study evaluates the use of ETC-1907206 in combination with dasatinib in certain types of blood cancers. The first phase of the study (1A) is designed to find the highest tolerated dose of ETC-1907206, while the second phase (1B) will assess the safety and tolerability of the recommended dose of ETC-1907206. ETC-1907206 has been designed to block the activity of an enzyme of the body known as Mnk kinase, which is thought to be involved in the development of a variety of cancers.
This study consists of two parts: a Phase 1A dose escalation to identify the MTD and the RD
of ETC-1907206 administered in combination with dasatinib and a Phase 1B expansion at the RD.
Phase 1A: A dose escalation with an adaptive design model using ordinal continual
reassessment method (oCRM) will be used to characterise the dose toxicity curve of
ETC-1907206 when administered orally every other day (EOD) under fasted conditions in
combination with oral once daily dasatinib (per locally approved product prescribing
instructions) in order to identify the maximum tolerated dose (MTD) and recommended dose (RD)
for Phase 1B.
Phase 1B: Open-label, non-randomised, to assess preliminary clinical activity and safety of
ETC-1907206 administered orally EOD under fasted conditions at the RD identified in Phase 1A,
in combination with dasatinib (per locally approved product prescribing instructions).
Patients will continue in the study until disease progression, the start of new anti-cancer
therapy, unacceptable toxicity, death, or the completion of 12 separate 4-week treatment
cycles, whichever occurs first.
As long as the Sponsor agrees to continue treatment, patients who complete 12 cycles of
treatment and have no evidence of disease progression are allowed to continue on treatment
past the end of treatment (EOT) visit until there is disease progression, unacceptable
toxicity, the patient decides to withdraw, or it is judged not to be in the patient's
interest to continue on the study.
Malignancy assessments of the underlying disease at enrolment (blood and bone marrow),
Eastern Cooperative Oncology Group (ECOG) performance status, pharmacokinetic (PK) sampling
for ETC-1907206 and dasatinib, sample collection for ETC-1907206 and dasatinib biomarker
analysis, and safety and tolerability assessments will be performed during the study.
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