Clinical Trial: NCT04603495 - My Cancer Genome

NCT04603495

Description:

A Phase 3, randomized, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been exposed previously to Janus kinase inhibitors (JAKi). CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Evidence suggests that inhibition of both BET and JAK pathways can result in synergistic reduction of disease and overall improvement in the prognosis of MF.

Related Conditions:

Myelofibrosis Transformation in Essential Thrombocythemia
Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
Primary Myelofibrosis

Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04603495

Trial Eligibility

Document

Title

Brief Title: Study of CPI-0610 in Myelofibrosis (MF)
Official Title: A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Clinical Trial IDs

ORG STUDY ID: 0610-04
SECONDARY ID: 2020-001989-10
NCT ID: NCT04603495

Conditions

Myelofibrosis
Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis

Interventions

Drug	Synonyms	Arms
CPI-0610		CPI-0610 + ruxolitinib
Ruxolitinib		CPI-0610 + ruxolitinib
Placebo		Placebo + ruxolitinib

Purpose

Trial Arms

Name	Type	Description	Interventions
CPI-0610 + ruxolitinib	Experimental	CPI-0610 monohydrate tablets + ruxolitinib phosphate tablets	CPI-0610 Ruxolitinib
Placebo + ruxolitinib	Active Comparator	Matching placebo tablets + ruxolitinib phosphate tablets	Ruxolitinib Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Aged ≥ 18 years

          -  Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post
             essential thrombocythemia)

          -  Adequate hematologic, renal, and hepatic function

          -  Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10
             over the 7-day period prior to randomization using the MFSAF v4.0

          -  Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International
             Prognostic Scoring System (DIPSS) scoring system

          -  Spleen volume of ≥ 450 cm^3

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

        Exclusion Criteria:

          -  Splenectomy or splenic irradiation in the previous 6 months

          -  Chronic or active conditions and/or concomitant medication use that would prohibit
             treatment

          -  Had prior treatment with any JAKi or BET inhibitor for treatment of a
             myeloproliferative neoplasm

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Splenic response at Week 24
Time Frame:	24 weeks of treatment
Safety Issue:
Description:	The primary endpoint of the study is splenic response, defined as a ≥35% reduction from baseline in spleen volume as measured by magnetic resonance imaging (MRI) or computerized tomography (CT), at Week 24.

Secondary Outcome Measures

Measure:	Total Symptom Score response at Week 24
Time Frame:	24 weeks of treatment
Safety Issue:
Description:	The key secondary endpoint of the study is Total Symptom Score response, defined as a ≥50% decrease from baseline in Total Symptom Score as measured by the Myelofibrosis Symptom Assessment Form v4.0, at Week 24. A higher Total Symptom Score indicates a higher disease burden and thus a worse outcome.

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Constellation Pharmaceuticals

Trial Keywords

Pelabresib
Ruxolitinib

Last Updated

August 31, 2021

Clinical Trials /

Study of CPI-0610 in Myelofibrosis (MF)