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The study was stopped due to patient enrollment challenges.
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Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control |
|
| orBec | Experimental | Investigational drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orBec | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States | ||
| Roswell Park Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug. Part 1: 2 mg of placebo 4 times per day for up to 16 weeks. Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule: Weeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
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| Placebo |
| Drug |
|
| Buffalo |
| New York |
| 14263 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| FG001 | orBec | orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug. Part 1: 2 mg of orBec 4 times per day for up to 16 weeks. Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule: Weeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Part 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Control Placebo |
| BG001 | orBec | Investigational drug orBec |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
48-week study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug. Part 1: 2 mg of placebo 4 times per day for up to 16 weeks. Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule: Weeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks. | 1 | 1 | 0 | 1 | ||
| EG001 | orBec | orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug. Part 1: 2 mg of orBec 4 times per day for up to 16 weeks. Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule: Weeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks. | 0 | 1 | 0 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| biliary strictures | Hepatobiliary disorders |
| |||
| fungal pneumonia | Infections and infestations |
| |||
| shortness of breath | Respiratory, thoracic and mediastinal disorders |
| |||
| pulmonary emboli | Vascular disorders |
| |||
| intractable pain | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Straube | Soligenix, Inc. | 609-538-8200 |
| ID | Term |
|---|---|
| C048053 | alpha-ketoisovalerate dehydrogenase phosphatase |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|