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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01789281
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : January 13, 2021
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
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
Actual Primary Completion Date : August 27, 2020
Actual Study Completion Date : August 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

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.

Primary Outcome Measures :
  1. Frequency and severity of AEs/SAEs [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. Percentage of patients with clinical benefit [ Time Frame: up to 8 years ]
    Percentage of patients with clinical benefits as assessed by the investigator at scheduled visits

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01789281

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01789281    
Other Study ID Numbers: CRAD001C2X01B
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Neoplasms, Carcinoid tumor, Neuroendocrine tumor
Additional relevant MeSH terms:
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Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal