Overview

This trial is active, not recruiting.

Condition acute graft versus host disease
Treatments incb039110 (200 mg), incb039110 (300 mg), prednisone or methylprednisolone (corticosteroids)
Phase phase 1
Target JAK1
Sponsor Incyte Corporation
Start date December 2015
End date June 2016
Trial size 31 participants
Trial identifier NCT02614612, INCB 39110-108

Summary

To determine if INCB039110 in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

United States California
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
INCB039110 (200 mg) + prednisone or methylprednisolone (corticosteroids)
incb039110 (200 mg)
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) + prednisone or methylprednisolone (corticosteroids)
incb039110 (300 mg)
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.

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized, Parallel-Cohort Phase 1 Study of INCB039110 in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.
Location data was received from the National Cancer Institute and was last updated in June 2016.