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

Phase 2

Terminated

• Conditions: Chronic Gastrointestinal Graft vs Host Disease
• Interventions: Drug: orBec; Drug: Placebo

• Registration Number: NCT01925950
• Lead Sponsor: Soligenix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Study Start: 2013-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2017-11-15
• Results First Submitted QC: 2018-09-07
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Results First Posted: 2018-10-04
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
orBec	orBec	Investigational drug
Placebo	Placebo	Control

Primary Outcome Measures

Name	Time	Method
Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms	16 weeks	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.

Trial Locations

Locations (3)

John Theurer Cancer Center; 🇺🇸 Hackensack, New Jersey, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States