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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01789281
First received: February 7, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Neoplasms
Drug: Everolimus
Drug: Sandostatin LAR Depot
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients receiving everolimus [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients experiencing serious adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 31
Study Start Date: May 2013
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789281

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

  Show 33 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01789281     History of Changes
Other Study ID Numbers: CRAD001C2X01B
Study First Received: February 7, 2013
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Neoplasms, Carcinoid tumor, Neuroendocrine tumor

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

ClinicalTrials.gov processed this record on November 20, 2014