Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
This study is not yet open for participant recruitment.
Verified February 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01789281
First received: February 7, 2013
Last updated: February 26, 2013
Last verified: February 2013
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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: | 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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Lactitol
Sirolimus
Octreotide acetate
Octreotide
Everolimus
Temsirolimus
U.S. FDA Resources
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: | 17 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789281
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, Arkansas | |
| Hematology Oncology Services of Arkansas SC | Not yet recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Carla Randall 501-320-3217 crandall@carti.com | |
| Principal Investigator: Brad Baltz | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers SC | Not yet recruiting |
| Greenwood Village, Colorado, United States | |
| Contact: Kathryn Schleich 303-730-4751 katherine.schleich@usoncology.com | |
| Principal Investigator: Richard McMahon | |
| United States, Connecticut | |
| Stamford Hospital | Not yet recruiting |
| Stamford, Connecticut, United States, 06902 | |
| Contact: Debra Flower 203-276-8447 dfowler@stamhealth.org | |
| Principal Investigator: Salvatore DelPrete | |
| United States, Indiana | |
| Central Indiana Cancer Centers SC | Not yet recruiting |
| Indianapolis, Indiana, United States, 46227 | |
| Contact: Yvonne LaFary 317-678-2739 YLafary@IUHealth.org | |
| Principal Investigator: Hillary Wu | |
| United States, Missouri | |
| Washington University School Of Medicine-Siteman Cancer Ctr Dept of Oncology | Not yet recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Ashley Bolden 314-747-8085 abolden@dom.wustl.edu | |
| Principal Investigator: Joel Picus | |
| United States, Texas | |
| US Oncology Central Monitoring | Not yet recruiting |
| Dallas, Texas, United States, 75246 | |
| Principal Investigator: Us Oncology | |
| United States, Virginia | |
| Virginia Oncology Associates SC | Not yet recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact 757-466-8683 | |
| Principal Investigator: Paul Conkling | |
| Czech Republic | |
| Novartis Investigative Site | Not yet recruiting |
| Praha 2, Czech Republic, 128 08 | |
| France | |
| Novartis Investigative Site | Not yet recruiting |
| Lyon, France, 69437 | |
| Italy | |
| Novartis Investigative Site | Not yet recruiting |
| Milano, MI, Italy, 20133 | |
| Netherlands | |
| Novartis Investigative Site | Not yet recruiting |
| Groningen, Netherlands, 9713 GZ | |
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: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Neoplasms, Carcinoid tumor, Neuroendocrine tumor |
Additional relevant MeSH terms:
|
Lactitol Neoplasms Octreotide Sirolimus Everolimus Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Gastrointestinal Agents Cathartics Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 17, 2013