Clinical trial NCT01263353: Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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,
Gastroenteropancreatic System
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
timeFrame: 15 months
measure: To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
timeFrame: 15 months
measure: To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
timeFrame: 12 months
measure: To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors
timeFrame: 15 months
measure: To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus
timeFrame: 15 months
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: