Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT01789281Other idCRAD001C2X01BOther id2012-004707-12

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 34 participants (actual)
Sponsor: Novartis Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 9 countries
United States, Czechia, Italy, Netherlands, Russia, South Korea, Spain, Thailand, Turkey (Türkiye)
Start: 14 May 2013
Primary completion: 28 Aug 2020
Completion: 28 Aug 2020
First posted: 12 Feb 2013 (estimated)
Last update posted: 11 Jun 2021
Conditions: Neoplasms

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2014201620182020

Ph 4
Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
NCT01789281
14 May 2013 to 28 Aug 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

EverolimusDrug
Sandostatin LAR DepotDrug

Arms1

Experimental
Everolimus
Participants who were receiving everolimus in a Novartis-sponsored study, were not progressing on the current study treatment and were unable to access everolimus treatment outside of a clinical trial. Participants receiving everolimus treatment in combination with Sandostatin LAR Depot on the parent protocol were allowed to continue Sandostatin LAR Depot treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame · SAEs collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approximately 7.2 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years
Registry description
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. All SAEs were captured in safety database from enrollment. Safety data collection was changed in the protocol amendment released in March 2016: AEs and SAEs were captured in the clinical database from protocol amendment release (18 March 2016). Hence, SAEs from both safety database and clinical database are summarized separately.

Secondary outcomes(1)

Percentage of Patients With Clinical Benefit
Time frame · After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years
Registry description
Percentage of patients with clinical benefit as judged by the investigator. Investigator attestation of continued clinical benefit was collected in clinical database after protocol amendment (release date 18 March 2016). Clinical benefit assessment before protocol amendment was done retrospectively.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· SAEs collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approximately 7.2 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Group	Value (Participants)
Everolimus	6
Everolimus+Sandostatin LAR	9

Secondary and other outcome results(1)

Secondary outcomeCount of participants· After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years

Percentage of Patients With Clinical Benefit

Group	Value (Participants)
Everolimus	9
Everolimus+Sandostatin LAR	7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
EverolimusParticipants who were receiving everolimus in a Novartis-sponsored study	1 / 22	6 / 22	3 / 22
Everolimus + Sandostatin LARParticipants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study	2 / 12	9 / 12	5 / 12
All SubjectsAll subjects	3 / 34	15 / 34	8 / 34

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subject enrolled in a Novartis-sponsored, CD\&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the parent study * Subject benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol. Exclusion Criteria: * Subject was permanently discontinued from everolimus study treatment in the parent study. * Subject was receiving everolimus in combination with an unapproved or experimental treatment Other protocol-defined inclusion/exclusion criteria might apply

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