Neoplasms
Conditions
Keywords
RAD001, everolimus, roll-over
Brief summary
The purpose of this study was to collect and assess long-term safety of everolimus in patients who were currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol, and were unable to access everolimus treatment outside of a clinical study. Parent studies eligible to participate in the roll-over study were decided by Novartis. Investigator initiated trials (IITs) were not included. The primary objective of the parent study must have been reached and the parent study must have been in the process of being completed and reported.
Detailed description
This was a multi-center, open label study to collect and assess long-term safety of everolimus in patients being treated in current Novartis-sponsored studies and who were benefiting from treatment with everolimus judged by the investigator.There was no screening period for this study. Eligible patients were consented and started their treatment with everolimus as soon as they entered the study. Patients had to return to the study center on a yearly basis (± 3 months), but for resupply of study medication, the frequency of the receipt and dispensing followed local practice (e.g., every 2 to 3 months). The dose of everolimus was based on the investigator's judgment. Adverse events (AEs) were collected continuously throughout the study. For the safe and effective use of everolimus, patient could return to the clinic at any given time following local practice. When AEs were observed, additional visits were arranged by investigator's discretion. Patients continued to be treated until they were no longer benefiting from everolimus as defined in the parent protocol (disease progression), developed unacceptable toxicities, withdrew consent, were non-compliant to the protocol, the investigator felt it is no longer in the patient's best interest to continue everolimus therapy or the patient died, whichever came first. A patient reached the end of study when everolimus treatment was permanently discontinued and the end of treatment visit had been performed. All patients were followed for AEs for 30 days after the last dose of everolimus. The study remained open for approximately 5 years; until such time that enrolled patients no longer needed treatment with everolimus, whichever came first.
Interventions
DRUGEverolimus
Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability | Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 5 years. | Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. |
Countries
Japan
Participant flow
Recruitment details
A total of 4 subjects were enrolled in the study and received at least one dose of everolimus. Of the 4 subjects, 2 subjects terminated treatment due to study closure by sponsor as approximately 5 years had elapsed since first patient first visit (FPFV). One subject terminated treatment due to an Adverse Event (AE) and one subject withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Everolimus Patients who received everolimus in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol and were unable to access everolimus treatment outside of a clinical trial were enrolled. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Everolimus |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 5 years.
Population: Safety Set-included all subjects who received at least one dose (partial or complete) of everolimus, and had at least one valid post-baseline safety assessment. The statement that a subject had no AEs (on the AEs eCRF) constituted a valid safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Everolimus | Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability | Participants who had at least one Adverse Event | 4 Count of Participants |
| Everolimus | Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability | Participants with Grade 3/4 Adverse Event | 2 Count of Participants |