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 : February 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Everolimus Drug: Sandostatin LAR Depot||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Frequency and severity of AEs/SAEs [ Time Frame: 10 years ]
- 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
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
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals||+41613241111|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|