Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
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| ClinicalTrials.gov Identifier: NCT01789281 |
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Recruitment Status :
Completed
First Posted : February 12, 2013
Last Update Posted : January 13, 2021
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 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 |
|---|---|
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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.
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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 :
- Frequency and severity of AEs/SAEs [ Time Frame: 8 years ]
Secondary Outcome Measures :
- 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
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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
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
Locations
Show 24 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov 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 ):
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Neoplasms, Carcinoid tumor, Neuroendocrine tumor |
Additional relevant MeSH terms:
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Neoplasms Everolimus Octreotide Antineoplastic Agents Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Antineoplastic Agents, Hormonal |