Pelabresib

DRUG9 trials

Sponsors

Constellation Pharmaceuticals, Novartis Pharmaceuticals

Conditions

Advanced MalignanciesAdvanced Malignancies and Hepatic ImpairmentBone Marrow DiseaseEssential ThrombocytosisHealthy ParticipantsHematologic MalignancyHematological DiseaseHematological Malignancy

Phase 1

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

CompletedNCT02158858

Constellation PharmaceuticalsBone Marrow Disease, Essential Thrombocytosis, Hematological Disease +11

Start: 2014-07-16End: 2025-01-09Updated: 2026-06-04

Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

CompletedNCT05391022

Constellation PharmaceuticalsAdvanced Malignancies, Hematological Malignancy, Solid Tumor

Start: 2021-07-20End: 2024-02-29Updated: 2025-07-28

Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis

Active, not recruitingNCT07340138

Novartis PharmaceuticalsPost-essential Thrombocythemia Myelofibrosis (Post-ET MF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), Primary Myelofibrosis (PMF)

Start: 2026-04-15End: 2030-09-21Updated: 2026-09-09

A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies

RecruitingNCT07340190

Novartis PharmaceuticalsAdvanced Malignancies

Start: 2026-06-12End: 2028-04-07Target: 24Updated: 2026-08-18

Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment

RecruitingNCT07422610

Novartis PharmaceuticalsAdvanced Malignancies and Hepatic Impairment

Start: 2026-04-24End: 2028-08-02Target: 24Updated: 2026-08-18

A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants

Not yet recruitingNCT07783503

Novartis PharmaceuticalsHealthy Participants

Start: 2026-08-27End: 2026-11-15Target: 30Updated: 2026-08-24

Phase 3

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

Active, not recruitingNCT04603495

Novartis PharmaceuticalsMyelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis +1

Start: 2021-04-09End: 2027-06-30Updated: 2026-07-17

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

RecruitingNCT06401356

Novartis PharmaceuticalsAdvanced Malignancies, Hematologic Malignancy, Solid Tumor

Start: 2024-08-13End: 2027-06-30Target: 50Updated: 2026-06-11

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

RecruitingNCT07357727

Novartis PharmaceuticalsPost-essential Thrombocythemia Myelofibrosis (PET-MF), Post-polycythemia Vera Myelofibrosis (PPV-MF), Primary Myelofibrosis (PMF)

Start: 2026-06-16End: 2030-12-27Target: 460Updated: 2026-09-09

Related Papers

Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 study

Blood2025-11-03

Pelabresib plus ruxolitinib for JAK inhibitor-naive myelofibrosis: a randomized phase 3 trial

Nature Medicine2025-03-1013 citations

Updated Results from the Phase 3 Manifest-2 Study of Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor-Naïve Patients with Myelofibrosis

Blood2024-11-056 citations

Updated safety and efficacy data from the phase 3 MANIFEST-2 study of pelabresib in combination with ruxolitinib for JAK inhibitor treatment-naïve patients with myelofibrosis.

Journal of Clinical Oncology2024-06-017 citations

Results from phase 1 of the MANIFEST clinical trial to evaluate the safety and tolerability of pelabresib in patients with myeloid malignancies

Leukemia & lymphoma/Leukemia and lymphoma2024-01-239 citations

JAK2 Inhibitors & Myelofibrosis

Oncology Times2023-12-05

Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor Treatment-Naïve Patients with Myelofibrosis: Results of the MANIFEST-2 Randomized, Double-Blind, Phase 3 Study

Blood2023-11-0228 citations

Matching-adjusted indirect comparison of the pelabresib-ruxolitinib combination vs JAKi monotherapy in myelofibrosis

Blood Advances2023-08-027 citations

P1018: UPDATED RESULTS FROM MANIFEST ARM 2: EFFICACY AND SAFETY OF PELABRESIB (CPI-0610) AS ADD-ON TO RUXOLITINIB IN MYELOFIBROSIS

HemaSphere2023-08-013 citations

S168: PELABRESIB (CPI-0610) MONOTHERAPY IN PATIENTS WITH HIGH-RISK ESSENTIAL THROMBOCYTHEMIA REFRACTORY OR INTOLERANT TO HYDROXYUREA: PRELIMINARY RESULTS FROM MANIFEST STUDY

HemaSphere2023-08-01

P1027: UPDATED DURABILITY OF RESPONSE AND SAFETY IN MANIFEST ARM 3: PELABRESIB (CPI-0610) COMBINED WITH RUXOLITINIB FOR JAK INHIBITOR TREATMENT-NAÏVE PATIENTS WITH MYELOFIBROSIS

HemaSphere2023-08-01

Pelabresib (CPI-0610) monotherapy in high-risk essential thrombocythemia refractory or intolerant to hydroxyurea: Preliminary results from MANIFEST study.

Journal of Clinical Oncology2023-06-011 citations

MANIFEST: Pelabresib in Combination With Ruxolitinib for Janus Kinase Inhibitor Treatment-Naïve Myelofibrosis

Journal of Clinical Oncology2023-03-0775 citations

Pelabresib (CPI-0610) As Add-on to Ruxolitinib in Myelofibrosis: Durability of Response and Safety Beyond Week 24 in the Phase 2 MANIFEST Study

Blood2022-11-1511 citations

Pelabresib (CPI-0610) Combined with Ruxolitinib for JAK Inhibitor Treatment-Naïve Patients with Myelofibrosis: Durability of Response and Safety Beyond Week 24

Blood2022-11-155 citations

Clinical Benefit Associated with Biomarker Changes Indicative of Disease Modification in Patients with Myelofibrosis Treated with the BET Inhibitor Pelabresib As Monotherapy or in Combination with Ruxolitinib

Blood2022-11-152 citations

Improvement in Individual Symptoms and Total Symptom Score (TSS) and Matching-Adjusted Indirect Comparison (MAIC) Analysis to Compare TSS As a Continuous Endpoint in Patients with Myelofibrosis Treated with Pelabresib in Combination with Ruxolitinib Versus Janus Kinase Inhibitor Monotherapy

Blood2022-11-15

Phase III MANIFEST-2: Pelabresib + Ruxolitinib vs Placebo + Ruxolitinib in JAK Inhibitor Treatment-Naive Myelofibrosis

Future Oncology2022-08-1136 citations

A Phase I Study of Pelabresib (CPI-0610), a Small-Molecule Inhibitor of BET Proteins, in Patients with Relapsed or Refractory Lymphoma

Cancer Research Communications2022-07-1533 citations

S198: BET INHIBITOR PELABRESIB (CPI-0610) COMBINED WITH RUXOLITINIB IN PATIENTS WITH MYELOFIBROSIS — JAK INHIBITOR-NAÏVE OR WITH SUBOPTIMAL RESPONSE TO RUXOLITINIB — PRELIMINARY DATA FROM THE MANIFEST STUDY

HemaSphere2022-06-018 citations

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