Clinical Trial: Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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).
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET [ Time Frame: 3 months ]
Original Primary Outcome: Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with progressive metastatic GEP-NET [ Time Frame: 3 months ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with progressive metastatic GEP-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 ]
Information By: Novartis
Dates:
Date Received: December 16, 2010
Date Started: November 2010
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016