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Trial record 3 of 16 for:    INCB039110

Study of INCB039110 in Combination With Corticosteroids for the Treatment of Acute GVHD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02614612
First received: November 20, 2015
Last updated: January 4, 2017
Last verified: January 2017
  Purpose
To determine if INCB039110 in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

Condition Intervention Phase
Acute Graft Versus Host Disease
Drug: INCB039110 (200 mg)
Drug: INCB039110 (300 mg)
Drug: prednisone or methylprednisolone (corticosteroids)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-Cohort Phase 1 Study of INCB039110 in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events [ Time Frame: First dose of study drug to 30 days after the last dose of study drug ]

Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Days 14, 28, 56 and 100 ]
  • Maximum Observed Plasma Concentration (Cmax) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
  • Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
  • Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
  • Minimum observed plasma concentration (Cmin) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]

Enrollment: 31
Study Start Date: December 2015
Estimated Study Completion Date: July 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB039110 (200 mg)
INCB039110 (200 mg) + prednisone or methylprednisolone (corticosteroids)
Drug: INCB039110 (200 mg) Drug: prednisone or methylprednisolone (corticosteroids)
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
Experimental: INCB039110 (300 mg)
INCB039110 (300 mg) + prednisone or methylprednisolone (corticosteroids)
Drug: INCB039110 (300 mg) Drug: prednisone or methylprednisolone (corticosteroids)
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
  • Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
  • Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
  • Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.

Exclusion Criteria:

  • Has received more than 1 hematopoietic stem cell transplantation.
  • Has progressed on more than 2 prior treatment regimens for acute GVHD.
  • Presence of an active uncontrolled infection.
  • Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
  • Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
  • Any corticosteroid therapy (for indications other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
  • Previously received JAK inhibitor therapy for any indication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02614612

  Show 23 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Patricia Delaite, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02614612     History of Changes
Other Study ID Numbers: INCB 39110-108
Study First Received: November 20, 2015
Last Updated: January 4, 2017

Keywords provided by Incyte Corporation:
Acute Graft Versus Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 25, 2017