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

NCT01925950 | Terminated Phase 2 Results

• 1 other identifier: BDP-GVHD-08
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control

Drug: Placebo

orBec

EXPERIMENTAL

Investigational drug

Drug: orBec

Interventions

orBec DRUG

Also known as: oral BDP, oral beclomethasone 17,21-dipropionate

orBec

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \>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

Sponsors & Collaborators

• Soligenix: lead

Study Sites (3)

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

alpha-ketoisovalerate dehydrogenase phosphatase

Results Point of Contact

• Title: Dr. Richard Straube
• Organization: Soligenix, Inc.

609-538-8200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 1, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-10

Locations

US (3)