Carcinoid TumorPhase 1NCT00446082
Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
A Phase 1 study testing Pasireotide in people with Carcinoid Tumor and Acromegaly, run by Novartis Pharmaceuticals at 17 sites in 6 countries.
Trial summary
This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Tumor, Acromegaly
- What is being tested?
- Pasireotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Jun 2006to Nov 2013
- Phase
- Phase 1
- 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
- Male or female patients between 18 and 80 years
- Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations
- Male or female patients aged ≥18 years
- Patients with histologically confirmed, metastatic carcinoid tumors of the digestive system
- Patients with elevation of chromogranin-A (CgA) and/or serotonin
- Patients who are not adequately controlled by somatostatin analogues
Who cannot join
- Patients with compression of the optic chiasm causing any visual field defect
- Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
- Female patients who are pregnant or lactating
- Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
- Female patients who are pregnant or lactating
- Other protocol-defined in- and exclusion criteria may apply.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Germany5 sites
Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Leipzig, 04317
Novartis Investigative Site
München, 80336
United States4 sites
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, 77030-4009
Cedars Sinai Medical Center SC - 4
Los Angeles, California, 90048
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, 94304
H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
Tampa, Florida, 33612
Belgium3 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Canada3 sites
Novartis Investigative Site
London, Ontario, N6A 4L6
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Toronto, Ontario, M5G1X5
About this study
Official title: A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease
This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease
- Conditions
- Carcinoid Tumor, Acromegaly
- Being tested
- Pasireotide
- Keywords
- Refractory/ resistant carcinoid disease, acromegaly, adults, pasireotide LAR, somatostatin analogue, SOM230, pharmacokinetics, Refractory or resistant carcinoid disease and acromegaly
- Medical subject headings
- Carcinoid Tumor, Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
| Study group | Role | What they receive |
|---|---|---|
| SOM230 LAR | Experimental | Not described Receives: Drug: Pasireotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
in patients with acromegaly and in patients with carcinoid disease
Measured: Baseline, D7, D35, D63
Secondary outcomes (1)
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
in patients with acromegaly and in patients with carcinoid disease.
Measured: Baseline, D7, D35, D63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJun 2006
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoid TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446082
- Sponsor's protocol ID
- CSOM230C2110
- Other IDs
- 2005-003348-75, 2005
- Status last verified
- Nov 2016
- First submitted
- 9 Mar 2007
- Last updated
- 21 Dec 2020
- Results posted
- No
Publications
Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Resendiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. J Clin Pharmacol. 2014 Nov;54(11):1308-17. doi: 10.1002/jcph.326. Epub 2014 May 24.
PubMed 24800725
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease
- ClinicalTrials.gov ID
- NCT00446082
- Acronym / sponsor ID
- CSOM230C2110
- Conditions
- Carcinoid Tumor, Acromegaly
- Keywords
- Refractory/ resistant carcinoid disease, acromegaly, adults, pasireotide LAR, somatostatin analogue, SOM230, pharmacokinetics, Refractory or resistant carcinoid disease and acromegaly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Mar 2007 (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.
This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOM230 LAR | Experimental | Drug: Pasireotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients between 18 and 80 years
- Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations
- Male or female patients aged ≥18 years
- Patients with histologically confirmed, metastatic carcinoid tumors of the digestive system
- Patients with elevation of chromogranin-A (CgA) and/or serotonin
Key exclusion criteria (6 listed)
- Patients with compression of the optic chiasm causing any visual field defect
- Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
- Female patients who are pregnant or lactating
- Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
- Female patients who are pregnant or lactating
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 | Drug | SOM230 LAR |
Primary outcome
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
Time frame: Baseline, D7, D35, D63
in patients with acromegaly and in patients with carcinoid disease
1 secondary outcome
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
Time frame: Baseline, D7, D35, D63
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 21 Dec 2020.
- Results publication: PubMed 24800725Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Resendiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. J Clin Pharmacol. 2014 Nov;54(11):1308-17. doi: 10.1002/jcph.326. Epub 2014 May 24.
- Novartis Clinical Trial Results for CSOM230C2110Link 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis study chair
Novartis
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pasireotide in people with Carcinoid Tumor and Acromegaly, run by Novartis Pharmaceuticals at 17 sites in 6 countries.
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 6 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, United States, Belgium, Canada, Netherlands and 1 more country. 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 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.
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?
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection (time frame: Baseline, D7, D35, D63). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446082, which also lists 1 linked publication.
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 21 Dec 2020.