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Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)

Primary Purpose

Chronic Gastrointestinal Graft vs Host Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
orBec
Placebo
Sponsored by
Soligenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Gastrointestinal Graft vs Host Disease focused on measuring BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant, marrow transplant, SCT, beclomethasone 17,21-dipropionate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent
  • Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
  • Endoscopic findings consistent with GI GVHD
  • Must be able to swallow tablets
  • Must be able to read and understand informed consent
  • Adequate birth control methods for the duration of the study

Exclusion Criteria:

  • >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
  • GI infection
  • Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • HIV seropositivity
  • Pregnant or nursing female
  • Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
  • Evidence of recurrent or progressing malignant disorder that was the indication for HCT

Sites / Locations

  • John Theurer Cancer Center
  • Roswell Park Cancer Institute
  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

orBec

Arm Description

Control

Investigational drug

Outcomes

Primary Outcome Measures

Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms
Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue. GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all subjects must have a score of ≥ 3. A CR will be defined as a composite score of 0.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2013
Last Updated
October 3, 2018
Sponsor
Soligenix
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1. Study Identification

Unique Protocol Identification Number
NCT01925950
Brief Title
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in Patients With Chronic GI GVHD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to patient enrollment challenges.
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soligenix

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gastrointestinal Graft vs Host Disease
Keywords
BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant, marrow transplant, SCT, beclomethasone 17,21-dipropionate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control
Arm Title
orBec
Arm Type
Experimental
Arm Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
orBec
Other Intervention Name(s)
oral BDP, oral beclomethasone 17,21-dipropionate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms
Description
Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue. GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all subjects must have a score of ≥ 3. A CR will be defined as a composite score of 0.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion) Endoscopic findings consistent with GI GVHD Must be able to swallow tablets Must be able to read and understand informed consent Adequate birth control methods for the duration of the study Exclusion Criteria: >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug GI infection Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study. HIV seropositivity Pregnant or nursing female Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug Evidence of recurrent or progressing malignant disorder that was the indication for HCT
Facility Information:
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)

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