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

NCT02158858 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2025-10-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Constellation Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2025-01-09
Completion
2025-01-09
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158858 on ClinicalTrials.gov