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

The purpose of this study is to allow continued use of everolimus in patients
who are currently receiving everolimus treatment in a Novartis-sponsored, 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 study. The roll-over study is designed to
accept patients with varied disease origins. 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.

Primary: To allow continued use of everolimus to patients receiving everolimus
in a Novartis-sponsored
study which has reached its objectives and who are benefitting from treatment
with everolimus as defined in the parent protocol

Secondary: To collect long term data on serious adverse events.

This is a multi-center, open label study to provide continued supply of
everolimus to patients currently being treated in a Novartis-sponsored Oncology
CD & MA study, who 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 study. Parent studies
eligible to participate in the roll-over study will be decided by Novartis.
Investigator initiated trials (IIT) will not be included.
There will be no screening period for this study. Patients must return to the
study center at least on a yearly basis (± 3 months) for resupply of study
medication. Limited drug dispensing information will be collected.
Study medication dispensed will be recorded on the dose administration page.
Reported serious adverse events will be collected continuously throughout the
study in the safety database.
Patients entering the roll-over protocol should be followed at the
investigator*s discretion for known or clinically notable adverse events that
occur on everolimus treatment as described in the current version of the IB.
The study is expected to remain open for 10 years or until such time that
enrolled patients no longer need treatment with everolimus or are able to
obtain commercial supply according to local regulations for their medical
condition.

Everolimus oral daily dose 5mg BID
Sandostatin LAR (once every 4 weeks) 30mg intramuscular injection

Side effects of everolimus and Sandostatin LAR.