EnteritisPhase 1/2NCT01073384
A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
A Phase 1/2 study testing SGX201 (delayed release beclomethasone 17,21-dipropionate) in people with Enteritis, run by Soligenix at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteritis
- What is being tested?
- SGX201 (delayed release beclomethasone 17,21-dipropionate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary rectal cancer
- Planned course of conventional neoadjuvant radiation therapy before surgery
- Scheduled to receive chemotherapy
- >/= 18 years of age
- Negative pregnancy test
Who cannot join
- History of acute or chronic regional enteritis or inflammatory bowel disease
- Stool incontinence
- Uncontrollable diarrhea
- Abdominal-perineal resection or other surgery leaving patient without a functioning rectum
- Patients using colostomy or ileostomy
- Liver function tests > 3x upper limit of normal, or bilirubin test result > 1.5 the upper limit of normal
Show all 18Show fewer
- Calculated creatinine clearance <60 mL/minute
- Planned hyperfractionated or split course radiation
- Planned brachytherapy prior to completion of all external beam radiation therapy
- Prior pelvic RT
- An on-going infection
- ECOG score >/= 3
- Leukopenia <2,000 WBC/mm3 or Hg <10.5 g/dL
- Participation in an investigational drug trial within the previous 30 days
- Patients with a medical condition that would interfere with study compliance
- Known hypersensitivity to 5-FU or capecitabine
- Anticipated inability to tolerate oral administration of SGX201
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University
Boston, Massachusetts
Northwestern University Medical Center
Chicago, Illinois
About this study
Official title: A Phase 1/2 Study to Evaluate Escalating Doses of SGX201 [Delayed Release Oral Beclomethasone Dipropionate (BDP)] for Prevention of Signs and Symptoms of Acute Enteritis in Patients With Rectal Cancer Treated With Combined Chemotherapy and Radiation Therapy
The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.
- Conditions
- Enteritis
- Being tested
- SGX201 (delayed release beclomethasone 17,21-dipropionate)
- Medical subject headings
- Enteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGX201 (delayed release beclomethasone 17,21-dipropionate)Drug
Also called beclomethasone 17,21-dipropionate, 17,-21 BDP
Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| BDP 3 mg | Experimental | 1 mg TID Receives: Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate) |
| BDP 6 mg | Experimental | 2 mg TID Receives: Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate) |
| BDP 9 mg | Experimental | 3 mg TID Receives: Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate) |
| BDP 12 mg | Experimental | 4 mg TID Receives: Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary Efficacy
Measured: One day prior to and 7 days after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soligenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kevin Horgan, MD, Principal investigator, Soligenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073384
- Sponsor's protocol ID
- BDP-ENT-01
- Other IDs
- 1R43CA141968-01
- Status last verified
- Dec 2012
- First submitted
- 19 Feb 2010
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Evaluate Escalating Doses of SGX201 [Delayed Release Oral Beclomethasone Dipropionate (BDP)] for Prevention of Signs and Symptoms of Acute Enteritis in Patients With Rectal Cancer Treated With Combined Chemotherapy and Radiation Therapy
- ClinicalTrials.gov ID
- NCT01073384
- Acronym / sponsor ID
- BDP-ENT-01
- Conditions
- Enteritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SoligenixIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BDP 3 mg | Experimental | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)1 mg TID |
| BDP 6 mg | Experimental | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)2 mg TID |
| BDP 9 mg | Experimental | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)3 mg TID |
| BDP 12 mg | Experimental | Drug: SGX201 (delayed release beclomethasone 17,21-dipropionate)4 mg TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary rectal cancer
- Planned course of conventional neoadjuvant radiation therapy before surgery
- Scheduled to receive chemotherapy
- >/= 18 years of age
- Negative pregnancy test
Key exclusion criteria (18 listed)
- History of acute or chronic regional enteritis or inflammatory bowel disease
- Stool incontinence
- Uncontrollable diarrhea
- Abdominal-perineal resection or other surgery leaving patient without a functioning rectum
- Patients using colostomy or ileostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGX201 (delayed release beclomethasone 17,21-dipropionate)Also: beclomethasone 17,21-dipropionate, 17,-21 BDPDelayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy. | Drug | BDP 12 mg, BDP 3 mg, BDP 6 mg, BDP 9 mg |
Primary outcome
Preliminary Efficacy
Time frame: One day prior to and 7 days after radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- SponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Horgan, MD principal investigator
Soligenix
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SGX201 (delayed release beclomethasone 17,21-dipropionate) in people with Enteritis, run by Soligenix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Efficacy (time frame: One day prior to and 7 days after radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.