CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 336 enrolled / 336 target
Drug / intervention
Pelabresib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02158858
NCT02158858Phase 1CompletedMonitor (2.3/mo)Completion was 17mo ago
CompareCT.gov

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

Constellation Pharmaceuticals·interventional·Posted Jun 9, 2014·Updated Jun 4, 2026

In Brief

A Phase 1 clinical trial evaluating Pelabresib and Ruxolitinib for Myelofibrosis and 13 related conditions. Completed, enrolled 336 participants across 48 sites in 9 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis, Leukemia, Myelocytic, Acute, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic Syndrome (MDS), Preleukemia, Primary Myelofibrosis, Myeloproliferative Disorders, Bone Marrow Disease, Hematological Disease, Precancerous Conditions, Neoplasms, Leukemia, Neoplasms by Histologic Type, Essential Thrombocytosis
CountriesBelgium, Canada, France, Germany, Italy, Netherlands, Poland, United Kingdom, United States
CollaboratorsThe Leukemia and Lymphoma Society

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 9, 2014
Enrollment StartJul 16, 2014
Primary CompletionJan 9, 2025
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 12.1 years ago

Arms & Interventions

Phase 1experimental

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).

Drug: Pelabresib
Phase 2 (Arm 1): Prior JAKi Monotherapy Arm (MF patients treated with pelabresib alone)experimental

* 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).

Drug: Pelabresib
Phase 2 (Arm 2): Prior JAKi Combination Armexperimental

* 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).

Drug: PelabresibDrug: Ruxolitinib
Phase 2 (Arm 3): JAKi Naïve Combination Armexperimental

Was open to patients with MF who had not previously received a JAKi (pelabresib (CPI-0610) + Ruxolitinib).

Drug: PelabresibDrug: Ruxolitinib
Phase 2 (Arm 4): Essential Thrombocythemia (ET) Monotherapy Armexperimental

Was open to high-risk patients with ET who were resistant or intolerant to hydroxyurea (HU) (pelabresib (CPI-0610) alone).

Drug: Pelabresib

Interventions

Pelabresibdrug

CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)

Ruxolitinibdrug

Ruxolitinib was given orally, twice daily (BID), on a continuous basis for 21 consecutive days of each 21-day cycle.