pelabresib
pelabresib: developed by 1 company · 9 clinical trials tracked.
pelabresib evidence translation
What we can confirm
9 tracked trials
What it means
What to watch
Prepared research question
How could pelabresib → CNST affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| CONSTELLATION PHARMACEUTICALS INC (CNST) | Phase 1/Phase 2 |
Clinical Trials (9)
A Phase 1, Two-part, Open-label, Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
Primary endpoint: Part 1 and 2: Maximum observed plasma concentration (Cmax) of pelabresib
A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies
Primary endpoint: Maximum Plasma Concentration (Cmax) of repaglinide, midazolam, and drospirenone and ethinyl estradiol
A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive
Primary endpoint: Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25
A Phase 1b, Open-Label, Multicenter Study to Evaluate the Pharmacokinetic Profile of Pelabresib (DAK539/CPI-0610) in Patients With Advanced Malignancies and Hepatic Impairment
Primary endpoint: Area Under the Curve from 0 to 24 hours on Day 14 (AUC₀-24h,D14) of pelabresib at steady state per study group
A Phase 1b Study of Pelabresib (DAK539) add-on to Stable Dose of Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Primary endpoint: Incidence of dose-limiting toxicities (DLTs)
An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib
Primary endpoint: Treatment-emergent adverse events (TEAEs) and serious TEAEs
A Phase 1, 2-Part Study to Evaluate the Effect of Food on Pharmacokinetics of Pelabresib (CPI-0610) and the Effect of Pelabresib on QTc in Patients With Advanced Malignancies
Primary endpoint: Run-In Food Effect Period: Area under the concentration time curve (AUC) based on pelabresib concentrations in plasma measured using validated plasma assay
A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients
Primary endpoint: Number of Participants With Splenic Response by Central Radiology Reads at Week 24
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)
Primary endpoint: Phase 1: Frequency of Dose-limiting Toxicities (DLTs)
Frequently asked questions
Who is developing pelabresib?
pelabresib is being developed by CONSTELLATION PHARMACEUTICALS INC.
How many clinical trials involve pelabresib?
BioSniper tracks 9 clinical trials involving pelabresib.