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Completed

NCT Number: NCT01263353

Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

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).

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Key information

Conditions

Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System Adenocarcinoma Carcinoid Tumor Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Bad Berka, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pasireotide LAR followed by Pasireotide LAR + Everolimus

Drug

Everolimus followed by Pasireotide LAR + Everolimus

Drug

Primary outcomes

  1. Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET

    Time frame: 3 months

Secondary outcomes

  1. Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET

    Time frame: 15 months

  2. To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy

    Time frame: 15 months

  3. To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy

    Time frame: 12 months

  4. 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

  5. To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: COOPERATE-1

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2010
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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