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