A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    271
  • sponsor
    Constellation Pharmaceuticals
Updated on 4 February 2021
platelet count
myelofibrosis
myelodysplastic syndromes
acute leukemia
myeloproliferative disorder
ruxolitinib
growth factor
leukemia
blast cells
janus kinase inhibitor
myelodysplastic/myeloproliferative neoplasms

Summary

Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis.

Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis.

CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Details
Condition Bone marrow disorder, Preleukemia, Acute myeloid leukemia, Myelodysplastic-Myeloproliferative Diseases, Myelosclerosis with myeloid metaplasia, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelofibrosis, myelodysplastic syndromes, myelodysplastic syndrome (mds)
Treatment Ruxolitinib, CPI-0610
Clinical Study IdentifierNCT02158858
SponsorConstellation Pharmaceuticals
Last Modified on4 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Myelofibrosis or MYELODYSPLASTIC SYNDROME or Preleukemia or Myelosclerosis with myeloid metaplasia or Myelodysplastic/Myeloproliferative Neoplasm, Unc...?
Do you have any of these conditions: myelodysplastic syndrome (mds) or Acute myeloid leukemia or Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) or Bone marrow disorde...?
Do you have any of these conditions: Myelodysplastic-Myeloproliferative Diseases or Acute myeloid leukemia or Acute Myelogenous Leukemia (AML) or Myelodysplastic/Myeloproliferative Neopla...?
Do you have any of these conditions: myelodysplastic syndrome (mds) or myelodysplastic syndromes or Myelodysplastic-Myeloproliferative Diseases or Bone marrow disorder or Myelodysplastic ...?
Do you have any of these conditions: Myelofibrosis or Bone marrow disorder or Myelodysplastic Syndromes (MDS) or myelodysplastic syndromes or Acute Myelogenous Leukemia (AML) or Myelodysp...?
Do you have any of these conditions: Acute myeloid leukemia or Acute Myelogenous Leukemia (AML) or Myelodysplastic-Myeloproliferative Diseases or MYELODYSPLASTIC SYNDROME or myelodysplast...?
Do you have any of these conditions: Myelofibrosis or Myelodysplastic Syndromes (MDS) or myelodysplastic syndrome (mds) or Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable or A...?
Adult (aged 18 years)
Phase 2 part: Patients with confirmed diagnosis of MF who meet all of the following
criteria
Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1 or higher
ANC 1 x 10^9/L without the assistance of granulocyte growth factors
Peripheral blood blast count <10%
ECOG performance status 2
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Patients must give written informed consent to participate in this study before the performance of any study-related procedure
For Arm 1 and 2 the following criteria should be considered
Palpable spleen 5 cm that is below the costal margin on physical examination OR RBC transfusion dependent (defined as an average of 2 units of RBC transfusions per month over the 12 weeks prior to enrollment)
At least 2 symptoms measurable (score 1) using the Myelofibrosis Symptom Assessment Form Version 4.0 (MFSAF v4.0)
Platelet count 75 x 10^9/L without the assistance of thrombopoietic factors or transfusions for at least 14 days
Monotherapy Arm (Arm 1): Previously treated with a JAK inhibitor and be intolerant, resistant, refractory or lost response to the JAK inhibitor
Combination Arm (Arm 2): Must have received single agent ruxolitinib and be on a stable dose for a minimum 8 weeks
For Arm 3 (JAK inhibitors nave) the following criteria should be considered
Platelet count 100 x 10^9/L without the assistance of thrombopoietic factors or transfusions
Palpable spleen 5 cm that is below the costal margin on physical examination
At least 2 symptoms measurable (score 3) or a total score of 10 using the MFSAF v4.0
No prior treatment with JAKi allowed

Exclusion Criteria

Current known active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
Impaired cardiac function or clinically significant cardiac diseases
Patients with Child-Pugh Class B or C
Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of CPI-0610 and/or ruxolitinib, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1
Prior treatment with a BET inhibitor
Pregnant or lactating women
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study
Patients unwilling or unable to comply with this study protocol
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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