Pancreatic NeoplasmPhase 2NCT00958841

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

A Phase 2 study testing pasireotide LAR in people with Pancreatic Neoplasm and Pituitary Neoplasm, run by Novartis Pharmaceuticals at 42 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Neoplasm, Pituitary Neoplasm, Nelson Syndrome
What is being tested?: pasireotide LAR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 42 sitesin 12 countries
Study dates: Sep 2009to Jun 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and Female Patients at least 18 years old
Patient who have rare tumors of neuroendocrine origin, such as tumors of the:
pancreas
pituitary glands
Nelson syndrome
ectopic-ACTH secreting tumor
Patients who have failed standard of care treatment or for whom no standard of care treatment exist
Signed Informed Consent

Who cannot join

Patients with active gallbladder disease
Patients with any ongoing or planned anti-neoplastic or interferon therapy
Poorly controlled diabetes mellitus
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

42 sites in 12 countries.

Country

City, postcode or hospital

42 sites in 12 countries

France8 sites

Novartis Investigative Site
Angers, 49033
Novartis Investigative Site
Bron, 69677
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Strasbourg, France, 67098

Other trials in France

Germany7 sites

Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
München, 80804
Novartis Investigative Site
Ulm, 89081
Novartis Investigative Site
Würzburg, 97080

Other trials in Germany

United States6 sites

Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)
Boston, Massachusetts, 02215
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, 90048
Cedars Sinai Medical Center The Pituitary Center (3)
Los Angeles, California, 90048
Mount Sinai School of Medicine Study Coordinator
New York, New York, 10029
Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)
Seattle, Washington
Stanford University Medical Center SC
Stanford, California, 94304

Other trials in United States

Italy5 sites

Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Roma, RM, 00168

Other trials in Italy

Brazil3 sites

Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-100
Novartis Investigative Site
Botucatu, São Paulo, 18618-970
Novartis Investigative Site
Fortaleza, Ceará, 60430-370

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Russia3 sites

Novartis Investigative Site
Moscow, 115478
Novartis Investigative Site
Moscow, 117036
Novartis Investigative Site
Saint Petersburg, 197341

Other trials in Russia

Australia2 sites

Novartis Investigative Site
Fitzroy, Victoria, 3065
Novartis Investigative Site
Westmead, New South Wales, 2145

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Canada2 sites

Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Novartis Investigative Site
Montreal, Quebec, H2L 2W5

Other trials in Canada

Spain2 sites

Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Málaga, Andalusia, 29010

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Thailand2 sites

Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10700

Other trials in Thailand

Argentina1 site

Novartis Investigative Site
Buenos Aires, Buenos Aires, C1264AAA

Other trials in Argentina

Mexico1 site

Novartis Investigative Site
Mexico City, Mexico City, 14269

Other trials in Mexico

About this study

Official title: An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Conditions: Pancreatic Neoplasm, Pituitary Neoplasm, Nelson Syndrome, Ectopic ACTH Syndrome
Being tested: pasireotide LAR
Keywords: Rare tumors of neuroendocrine origin, NETs of the pancreatic, Pituitary NETs, EAS Tumors, Nelson's Syndrome, Pancreatic neoplasm, pituitary neoplasm, Nelson Syndrome, ectopic ACTH syndrome, pasireotide LAR, PNETs, PiNETS
Medical subject headings: Pancreatic Neoplasms, Pituitary Neoplasms, Nelson Syndrome, ACTH Syndrome, Ectopic, Neuroectodermal Tumors, Primitive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pasireotide LARDrug
Also called SOM230
Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.

Study groups in NCT00958841
Study group	Role	What they receive
pasireotide LAR 60mg	Experimental	Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Receives: Drug: pasireotide LAR

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
Measured: 6 months

Secondary outcomes (5)

Percentage of Responders at Month 6 - Individual NETs
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
Measured: 6 months
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
Measured: 6 months
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
Measured: Baseline, month 6
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
Measured: Baseline, month 6
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.
Measured: Baseline, month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jun 2015

First posted13 Aug 2009 (estimated)
Study startSep 2009
Primary completionJun 2015
Study completionJun 2015

Why it stopped: Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues)

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 Pancreatic NeoplasmStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958841
Sponsor's protocol ID: CSOM230D2203
Other IDs: 2008-007348-32, 2008
Status last verified: Jun 2016
First submitted: 22 Jul 2009
Last updated: 26 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin
ClinicalTrials.gov ID: NCT00958841
Acronym / sponsor ID: CSOM230D2203
Conditions: Pancreatic Neoplasm, Pituitary Neoplasm, Nelson Syndrome, Ectopic ACTH Syndrome
Keywords: Rare tumors of neuroendocrine origin, NETs of the pancreatic, Pituitary NETs, EAS Tumors, Nelson's Syndrome, Pancreatic neoplasm, pituitary neoplasm, Nelson Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues)
Enrolment: 118 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Aug 2009 (estimated)
Results: Posted 26 Jul 2016

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 effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
pasireotide LAR 60mg	Experimental	Drug: pasireotide LARPatients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and Female Patients at least 18 years old
Patient who have rare tumors of neuroendocrine origin, such as tumors of the:
Patients who have failed standard of care treatment or for whom no standard of care treatment exist
Signed Informed Consent

Key exclusion criteria (5 listed)

Patients with active gallbladder disease
Patients with any ongoing or planned anti-neoplastic or interferon therapy
Poorly controlled diabetes mellitus
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control
Other protocol-defined inclusion/exclusion criteria may apply.

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 LARAlso: SOM230Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.	Drug	pasireotide LAR 60mg

Primary outcome

Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
Time frame: 6 months
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.

5 secondary outcomes

Percentage of Responders at Month 6 - Individual NETs
Time frame: 6 months
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
Time frame: 6 months
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Time frame: Baseline, month 6
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Time frame: Baseline, month 6
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Time frame: Baseline, month 6

Results and safety

Results posted to the registry on 26 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pasireotide LAR 60mg	118	22

Primary outcome: Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)

Time frame: 6 months. Number. Unit: percentage of participants

Measure	Gastrinoma n = 13	VIpoma n = 2	Glucagonoma n = 5
Value	46.2	0.0	0.0

Population analysed: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pancreatic NETs (PNETs)	10 of 25 (40%)	23 of 25 (92%)	Not reported
Pituitary NETs (PiNETs)	8 of 72 (11.1%)	71 of 72 (98.6%)	Not reported
Ectopic ACTH-secrting Tumors (EAS)	5 of 7 (71.4%)	7 of 7 (100%)	Not reported
Nelsons Syndrome	9 of 14 (64.3%)	14 of 14 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

42 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pasireotide LAR in people with Pancreatic Neoplasm and Pituitary Neoplasm, run by Novartis Pharmaceuticals at 42 sites in 12 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 8 inclusion and 5 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in France, Germany, United States, Italy, Brazil and 7 more countries. 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 26 Jul 2016). 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?

Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs) (time frame: 6 months). 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 NCT00958841.

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 26 Jul 2016.