Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System Clinical Trial
— COOPERATE-1Official 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
| Verified date | April 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis Investigative Site | Bad Berka | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Marburg | |
| Germany | Novartis Investigative Site | Muenster |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET | 3 months | ||
| Secondary | Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET | 15 months | ||
| Secondary | To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy | 15 months | ||
| Secondary | To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy | 12 months | ||
| Secondary | To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors | 15 months | ||
| Secondary | To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus | 15 months |