Trials / Completed
CompletedNCT02158858
A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 336 (actual)
- Sponsor
- Constellation Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1 Part: Open-label, sequential dose escalation study of pelabresib (CPI-0610) in patients with previously treated Acute Leukemia, Myelodysplastic/Myeloproliferative Neoplasms, and Phase 2 Part: Open-label study of pelabresib (CPI-0610) with and without Ruxolitinib in patients with Myeloproliferative Neoplasms (Myelofibrosis and Essential Thrombocythemia). Pelabresib (CPI-0610) is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
Conditions
- Myelofibrosis
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pelabresib | CPI-0610 is administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days) |
| DRUG | Ruxolitinib | Ruxolitinib is given orally, twice daily (BID), on a continuous basis for 21 consecutive days of each 21-day cycle. |
Timeline
- Start date
- 2014-07-16
- Primary completion
- 2025-01-09
- Completion
- 2025-01-09
- First posted
- 2014-06-09
- Last updated
- 2025-10-08
Locations
48 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02158858. Inclusion in this directory is not an endorsement.