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Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.

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ClinicalTrials.gov Identifier: NCT01789281
Recruitment Status : Recruiting
First Posted : February 12, 2013
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
Study to allow access to everolimus for patients who are on everolimus treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Everolimus Drug: Sandostatin LAR Depot Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study and Are Judged by the Investigator to Benefit From Continued Everolimus Treatment
Actual Study Start Date : May 14, 2013
Estimated Primary Completion Date : May 12, 2023
Estimated Study Completion Date : May 12, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Everolimus
Patients who are receiving everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that has reached its study objectives, are not progressing on the current study treatment as defined by the parent protocol and are unable to access everolimus treatment outside of a clinical trial will be allowed to enroll. If patients are receiving treatment of everolimus in combination with other approved therapies, they can participate in the roll-over study, but it is not intended for combination with unapproved or experimental treatments. Patients who meet all inclusion and none of the exclusion criteria will be treated with the same daily everolimus dose they are receiving in the parent protocol until disease progression (as defined in the parent protocol), unacceptable toxicity develops, consent withdrawl, protocol non-compliance, the investigator feels it is no longer in the patient's best interest to continue therapy, or the patient's death.
 Drug: Everolimus
Everolimus will be provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. Everolimus can be provided as local commercial material or global supply where appropriate

Drug: Sandostatin LAR Depot
Patients receiving everolimus treatment in combination with Sandostatin LAR Depot on the parent protocol will be allowed to continue Sandostatin LAR Depot treatment. Sandostatin LAR Depot will continue to be provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections will be administered at the discretion of the treating physician.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and severity of AEs/SAEs [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Percentage of patients with clinical benefit [ Time Frame: up to 10 years ]
    Percentage of patients with clinical benefits as assessed by the investigator at scheduled visits


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is currently enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and has fulfilled all their requirements in the parent study
  • Patient is currently benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol.

Exclusion Criteria:

  • Patient has been permanently discontinued from everolimus study treatment in the parent study.
  • Patient is receiving everolimus in combination with an unapproved or experimental treatment
  • Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789281


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01789281     History of Changes
Other Study ID Numbers: CRAD001C2X01B
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Neoplasms, Carcinoid tumor, Neuroendocrine tumor

Additional relevant MeSH terms:
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Neoplasms
Sirolimus
Everolimus
Octreotide
Lactitol
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Cathartics
Gastrointestinal Agents
Antineoplastic Agents, Hormonal