Carcinoid TumorsPhase 2NCT00088595
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
A Phase 2 study testing Pasireotide (SOM230) in people with Carcinoid Tumors, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
Study evaluating SOM230 in patients with metastatic carcinoid tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoid Tumors
- What is being tested?
- Pasireotide (SOM230)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2004to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with biopsy-proven metastatic carcinoid tumors
- Patients with at least one measurable lesion (excluding bone)
- Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day
Who cannot join
- Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
- Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
- Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
- Patients with uncontrolled diabetes mellitus
- Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
- Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment
Show all 13Show fewer
- Patients with chronic liver disease
- Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
- History of immunocompromise, including a positive HIV test result
- Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230
- Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230
- Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
- Patients with additional active malignant disease within the last five years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Univ. Of Iowa Holden Cancer Center
Iowa City, Iowa, 52242
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Louisiana State University Medical Center
New Orleans, Louisiana, 70112
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
Study evaluating SOM230 in patients with metastatic carcinoid tumors
- Conditions
- Carcinoid Tumors
- Being tested
- Pasireotide (SOM230)
- Keywords
- SOM230, Sandostatin, Carcinoid syndrome
- Medical subject headings
- Carcinoid Tumor, Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide (SOM230)Drug
Also called SOM230
Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide | Experimental | Not described Receives: Drug: Pasireotide (SOM230) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.
Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.
Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
Measured: 15 days
Secondary outcomes (4)
Duration of Complete Symptom Control (Days) by Dose Class
Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.
Measured: 15 days
Duration of Partial Symptom Control (Days) by Dose Class
Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.
Measured: up to 15 days
The Number of Patients (Participants) With Overall Tumor Response
The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.
Measured: At least 15 days
The Overall Safety and Tolerability of Pasireotide
Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.
Measured: At least 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study startJan 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088595
- Sponsor's protocol ID
- CSOM230B2202
- Status last verified
- May 2012
- First submitted
- 30 Jul 2004
- Last updated
- 4 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
- ClinicalTrials.gov ID
- NCT00088595
- Acronym / sponsor ID
- CSOM230B2202
- Conditions
- Carcinoid Tumors
- Keywords
- SOM230, Sandostatin, Carcinoid syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Aug 2004 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study evaluating SOM230 in patients with metastatic carcinoid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide | Experimental | Drug: Pasireotide (SOM230) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with biopsy-proven metastatic carcinoid tumors
- Patients with at least one measurable lesion (excluding bone)
- Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day
Key exclusion criteria (13 listed)
- Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
- Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
- Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
- Patients with uncontrolled diabetes mellitus
- Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
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 |
|---|---|---|
| Pasireotide (SOM230)Also: SOM230Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred. | Drug | Pasireotide |
Primary outcome
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Time frame: 15 days
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
4 secondary outcomes
Duration of Complete Symptom Control (Days) by Dose Class
Time frame: 15 days
Duration of Partial Symptom Control (Days) by Dose Class
Time frame: up to 15 days
The Number of Patients (Participants) With Overall Tumor Response
Time frame: At least 15 days
The Overall Safety and Tolerability of Pasireotide
Time frame: At least 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Carcinoid Tumors
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pasireotide (SOM230) in people with Carcinoid Tumors, run by Novartis Pharmaceuticals at 4 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 3 inclusion and 13 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 6 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary (time frame: 15 days). 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 4 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.