A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Constellation Pharmaceuticals
Study ID
NCT02158858
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Bone Marrow Disease
  • Essential Thrombocytosis
  • Hematological Disease
  • Leukemia
  • Leukemia, Myelocytic, Acute
  • Myelodysplastic Syndrome (MDS)
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Neoplasms
  • Neoplasms by Histologic Type
  • Precancerous Conditions
  • Preleukemia
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelabresib — DRUG
    CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)
  • Ruxolitinib — DRUG
    Ruxolitinib was given orally, twice daily (BID), on a continuous basis for 21 consecutive days of each 21-day cycle.

Study Details

Phase 1 Part: This was an open-label, sequential dose escalation study of pelabresib (CPI-0610) in patients who had previously been treated for Acute Leukemia, Myelodysplastic/Myeloproliferative Neoplasms. Phase 2 Part: This was an open-label study of pelabresib (CPI-0610), administered with and without Ruxolitinib, in patients diagnosed with Myeloproliferative Neoplasms (Myelofibrosis and Essential Thrombocythemia). Pelabresib (CPI-0610) was a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Key Dates

Start date
Jul 16, 2014
Status verified
Apr 2026
Primary completion
Jan 9, 2025
Completion
Jan 9, 2025

Study Design

Enrollment
336 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    Patients were enrolled in sequential cohorts (acute leukemia, including acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and acute undifferentiated or biphenotypic leukemia; chronic myelogenous leukemia (CML) in blast crisis; myelodysplastic syndrome (MDS); myelodysplastic/myeloproliferative neoplasms (MDS/MPN); or myelofibrosis (MF)) and received escalating doses of pelabresib (CPI-0610).
  • Experimental: Phase 2 (Arm 1): Prior JAKi Monotherapy Arm (MF patients treated with pelabresib alone)
    * Cohort 1A: Was open to patients with MF who were Transfusion Dependent (TD) and who had previously been treated with a JAKi and were intolerant, resistant, refractory, or had lost response to the JAKi, or were ineligible to be treated with a JAKi (pelabresib (CPI-0610) alone). * Cohort 1B: Was open to patients with MF who were not TD and who had previously been treated with a JAKi and were intolerant, resistant, refractory, or had lost response to the JAKi, or were ineligible to be treated with a JAKi (pelabresib (CPI-0610) alone).
  • Experimental: Phase 2 (Arm 2): Prior JAKi Combination Arm
    * Cohort 2A: Was open to patients with MF who were Transfusion Dependent (TD) and were taking ruxolitinib but had disease that was not adequately controlled by ruxolitinib (pelabresib (CPI-0610) + Ruxolitinib). * Cohort 2B: Was open to patients with MF who were not TD and were taking ruxolitinib but had disease that was not adequately controlled by ruxolitinib (pelabresib (CPI-0610) + Ruxolitinib).
  • Experimental: Phase 2 (Arm 3): JAKi Naïve Combination Arm
    Was open to patients with MF who had not previously received a JAKi (pelabresib (CPI-0610) + Ruxolitinib).
  • Experimental: Phase 2 (Arm 4): Essential Thrombocythemia (ET) Monotherapy Arm
    Was open to high-risk patients with ET who were resistant or intolerant to hydroxyurea (HU) (pelabresib (CPI-0610) alone).

Primary Outcome Measure

Phase 1: Frequency of Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
UCLA Medical CenterLos AngelesCalifornia90095-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Northwestern University - Lurie Comprehensive Cancer CenterChicagoIllinois60611-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
University of Michigan Medical CenterAnn ArborMichigan48109-
Washington University School of Medicne Neuromuscular Division Department of Neurology ResearchSt LouisMissouri63110-
ICAHN School of Medicine at Mount SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Weill Medical College and New York Presbyterian HospitalNew YorkNew York10065-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Froedtert & Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Arizona· Phoenix, AZUCLA Medical Center· Los Angeles, CAMayo Clinic Jacksonville· Jacksonville, FLNorthwestern University - Lurie Comprehensive Cancer Center· Chicago, ILMassachusetts General Hospital Cancer Center· Boston, MAUniversity of Michigan Medical Center· Ann Arbor, MI

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