Carcinoid SyndromePhase 1/2NCT00884715
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
A Phase 1/2 study testing Octreotide in people with Carcinoid Syndrome, run by Endo USA Inc., a Keenova Therapeutics Company at 3 sites in United States.
Trial summary
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoid Syndrome
- What is being tested?
- Octreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Dec 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed tumor
- documented evidence of carcinoid syndrome
- life expectancy of at least 6 months
- previous positive octreotide scan
- received stable doses of octreotide injections
- performance status of 0-2 on the ECOG performance scale
Who cannot join
- poorly differentiated or high grade neuroendocrine tumor
- significant cv, hepatic, renal or other disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boston, Massachusetts, 02115
Study site
Burlington, Massachusetts, 01805
Study site
Iowa City, Iowa, 52242
About this study
Official title: Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
Read the detailed description
This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.
- Conditions
- Carcinoid Syndrome
- Being tested
- Octreotide
- Medical subject headings
- Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
short acting octreotide
| Study group | Role | What they receive |
|---|---|---|
| 1 implant | Experimental | 117 mg Octreotide implant Receives: Drug: Octreotide |
| 2 implants | Experimental | 234 mg Octreotide implant Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
Measured: 9 months
Secondary outcomes (1)
safety and tolerability of the implants
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2011
- Study completionDec 2011
Why it stopped: Program was terminated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid SyndromeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884715
- Sponsor's protocol ID
- IP107-002
- Status last verified
- Sep 2013
- First submitted
- 20 Apr 2009
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
- ClinicalTrials.gov ID
- NCT00884715
- Acronym / sponsor ID
- IP107-002
- Conditions
- Carcinoid Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program was terminated for business reasons
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Apr 2009 (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.
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
Detailed description
This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 implant | Experimental | Drug: Octreotide117 mg Octreotide implant |
| 2 implants | Experimental | Drug: Octreotide234 mg Octreotide implant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed tumor
- documented evidence of carcinoid syndrome
- life expectancy of at least 6 months
- previous positive octreotide scan
- received stable doses of octreotide injections
Key exclusion criteria (2 listed)
- poorly differentiated or high grade neuroendocrine tumor
- significant cv, hepatic, renal or other disease
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 |
|---|---|---|
| Octreotideshort acting octreotide | Drug | 1 implant, 2 implants |
Primary outcome
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
Time frame: 9 months
1 secondary outcome
safety and tolerability of the implants
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Program was terminated for business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Click here for more information about this studyLink 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Octreotide in people with Carcinoid Syndrome, run by Endo USA Inc., a Keenova Therapeutics Company at 3 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Program was terminated for business reasons). Results are not available in the source record.
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?
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea (time frame: 9 months). 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 20 Sep 2013.