Pelabresib

DRUG8 trials

Sponsors

Constellation Pharmaceuticals, Novartis Pharmaceuticals

Conditions

Advanced MalignanciesAdvanced Malignancies and Hepatic ImpairmentBone Marrow DiseaseEssential ThrombocytosisHematologic MalignancyHematological DiseaseHematological MalignancyLeukemia

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: 2025-10-08

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

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

Not yet recruitingNCT07340190

Novartis PharmaceuticalsAdvanced Malignancies

Start: 2026-05-29End: 2028-04-07Target: 24Updated: 2026-04-02

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

Not yet recruitingNCT07340138

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

Start: 2026-05-07End: 2030-12-18Target: 6Updated: 2026-04-02

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

Not yet recruitingNCT07422610

Novartis PharmaceuticalsAdvanced Malignancies and Hepatic Impairment

Start: 2026-05-18End: 2028-09-04Target: 24Updated: 2026-04-02

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: 2025-12-17

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: 2025-06-22

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

Not yet recruitingNCT07357727

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

Start: 2026-04-17End: 2030-12-02Target: 460Updated: 2026-04-02

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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