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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004707-12-CZ

Enrollment

Registered

2013-03-01

Start date

2013-05-16

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease corresponding to the Novartis-sponsored study the patient will be transitioning from

Interventions

Trade Name: Afinitor Product Name: Everolimus Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient is currently enrolled in a Novartis-sponsored, OGD & GMA study receiving everolimus or everolimus plus Sandostatin LAR® Depot and has fulfilled all their requirements in the parent study. 2. Patient is currently benefiting from the treatment with everolimus, as determined by the guidelines of the parent protocol. Other protocol defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: 1. Patient has been permanently discontinued from everolimus study treatment in the parent study. 2. Patient is receiving everolimus in combination with unapproved or experimental treatments. Other protocol defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate long term safety data.;Secondary Objective: To evaluate clinical benefit as assessed by the investigator.;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: 10 years	—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits ;Timepoint(s) of evaluation of this end point: 10 years	—

Countries

Czech Republic, Italy, Korea, Republic of, Netherlands, Russian Federation, Spain, Thailand, United States

Contacts

Public ContactInformacní služba – klin. hodnocení

Novartis s.r.o.

dotazy.klinickehodnoceni@novartis.com+420225775 111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026