Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic SystemPhase 1COOPERATE-1NCT01263353
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
A Phase 1 study testing Pasireotide LAR followed by Pasireotide LAR + Everolimus and Everolimus followed by Pasireotide LAR + Everolimus in people with Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System, run by Novartis Pharmaceuticals at 4 sites in Germany.
Trial summary
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
- What is being tested?
- Pasireotide LAR followed by Pasireotide LAR + Everolimus and Everolimus followed by Pasireotide LAR + Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 2010to Mar 2014
- 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
- Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
- Progressive disease within last 12 months (only patients with nonfunctional tumors)
- Documented liver metastasis
- Measurable disease per RECIST determined by multiphase MRI or triphasic CT
Who cannot join
- Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
- Previous treatment with mTOR inhibitors or pasireotide
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Women who are pregnant or lactating
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Novartis Investigative Site
Bad Berka, 99438
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
Münster, 48149
About this study
Official title: An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
- Being tested
- Pasireotide LAR followed by Pasireotide LAR + Everolimus, Everolimus followed by Pasireotide LAR + Everolimus
- Keywords
- Carcinoid tumor,, Gastroenteropancreatic Neuroendocrine Tumors,, Pulmonary Neuroendocrine Tumors,, pasireotide LAR,, SOM230 LAR,, everolimus,, RAD001,, Advanced Neuroendocrine Tumor,, Gastroenteropancreatic System
- Medical subject headings
- Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide LAR followed by Pasireotide LAR + EverolimusDrug
Everolimus followed by Pasireotide LAR + EverolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Functional tumors, pre-treated | Experimental | Not described Receives: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Functional tumors, treatment naïve | Experimental | Not described Receives: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, pretreated 1 | Experimental | Not described Receives: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, pretreated 2 | Experimental | Not described Receives: Drug: Everolimus followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, treatment-naïve 1 | Experimental | Not described Receives: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, treatment-naïve 2 | Experimental | Not described Receives: Drug: Everolimus followed by Pasireotide LAR + Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Measured: 3 months
Secondary outcomes (5)
Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
Measured: 15 months
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
Measured: 15 months
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
Measured: 12 months
To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors
Measured: 15 months
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic SystemStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01263353
- Sponsor's protocol ID
- CSOM230F2102
- Other IDs
- 2010-018895-26
- Acronym
- COOPERATE-1
- Status last verified
- Apr 2016
- First submitted
- 16 Dec 2010
- Last updated
- 21 Dec 2020
- Results posted
- No
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
- An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
- ClinicalTrials.gov ID
- NCT01263353
- Acronym / sponsor ID
- COOPERATE-1 / CSOM230F2102
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
- Keywords
- Carcinoid tumor,, Gastroenteropancreatic Neuroendocrine Tumors,, Pulmonary Neuroendocrine Tumors,, pasireotide LAR,, SOM230 LAR,, everolimus,, RAD001,, Advanced Neuroendocrine Tumor,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Dec 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 assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Functional tumors, pre-treated | Experimental | Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Functional tumors, treatment naïve | Experimental | Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, pretreated 1 | Experimental | Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, pretreated 2 | Experimental | Drug: Everolimus followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, treatment-naïve 1 | Experimental | Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus |
| Nonfunctional tumors, treatment-naïve 2 | Experimental | Drug: Everolimus followed by Pasireotide LAR + Everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
- Progressive disease within last 12 months (only patients with nonfunctional tumors)
- Documented liver metastasis
- Measurable disease per RECIST determined by multiphase MRI or triphasic CT
Key exclusion criteria (5 listed)
- Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
- Previous treatment with mTOR inhibitors or pasireotide
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Women who are pregnant or lactating
- 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 LAR followed by Pasireotide LAR + Everolimus | Drug | Functional tumors, pre-treated, Functional tumors, treatment naïve, Nonfunctional tumors, pretreated 1, Nonfunctional tumors, treatment-naïve 1 |
| Everolimus followed by Pasireotide LAR + Everolimus | Drug | Nonfunctional tumors, pretreated 2, Nonfunctional tumors, treatment-naïve 2 |
Primary outcome
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Time frame: 3 months
5 secondary outcomes
Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
Time frame: 15 months
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
Time frame: 15 months
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
Time frame: 12 months
To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors
Time frame: 15 months
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus
Time frame: 15 months
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 for CSOM230F2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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 1 study testing Pasireotide LAR followed by Pasireotide LAR + Everolimus and Everolimus followed by Pasireotide LAR + Everolimus in people with Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System, run by Novartis Pharmaceuticals at 4 sites in Germany.
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 4 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: 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 4 sites in Germany. 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?
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET (time frame: 3 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 21 Dec 2020.