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



Status:Recruiting
Conditions:Other Indications, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:June 2014
End Date:March 2020
Contact:Debbie Johnson
Email:debbie.johnson@constellationpharma.com
Phone:617-714-0555

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A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis)

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.


Inclusion Criteria

- 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; see Appendix 3) 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 naïve) 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

- Anemic, defined as a hemoglobin < 10g/dL

- 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.
We found this trial at
11
sites
Lafayette, Indiana 47905
Principal Investigator: Wael Harb, MD
Phone: 765-446-5111
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Amir Fathi, MD
Phone: 617-724-1124
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Ann Arbor, Michigan 48109
Principal Investigator: Moshe Talpaz, MD
Phone: 734-936-2712
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Gabrail, MD
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Edmonton, Alberta
Principal Investigator: Elena Liew, MD
Phone: 780-407-1811
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Houston, Texas 77030
Principal Investigator: Prithviraj Bose, MD
Phone: 713-792-9116
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Houston, TX
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Gary Schiller, MD
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Eytan Stein, MD
Phone: 212-639-3314
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Marina Kremyanskya, MD PhD
Phone: 212-241-8999
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, New York 10032
Principal Investigator: Mark Heaney
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Philadelphia, Pennsylvania 19104
Principal Investigator: James Mangan, MD
Phone: 215-662-4610
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