Trial Outcomes & Findings for Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator. (NCT NCT02017860)
NCT ID: NCT02017860
Last Updated: 2020-04-30
Results Overview
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
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.
Results posted on
2020-04-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator.
Baseline characteristics by cohort
| Measure |
Everolimus
n=4 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Outcome measures
| Measure |
Everolimus
n=4 Participants
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.
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|---|---|
|
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
|
|
Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability
Participants with Grade 3/4 Adverse Event
|
2 Count of Participants
|
Adverse Events
Everolimus
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus
n=4 participants at risk
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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
25.0%
1/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • 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.
|
Other adverse events
| Measure |
Everolimus
n=4 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
50.0%
2/4 • 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.
|
|
Gastrointestinal disorders
Dental caries
|
25.0%
1/4 • 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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
1/4 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
2/4 • 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.
|
|
General disorders
Oedema peripheral
|
50.0%
2/4 • 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.
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • 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.
|
|
Infections and infestations
Dermatophytosis of nail
|
25.0%
1/4 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • 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.
|
|
Infections and infestations
Rhinitis
|
50.0%
2/4 • 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.
|
|
Investigations
Blood creatinine increased
|
50.0%
2/4 • 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.
|
|
Investigations
Blood phosphorus decreased
|
25.0%
1/4 • 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.
|
|
Investigations
Haemoglobin decreased
|
25.0%
1/4 • 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.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
25.0%
1/4 • 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.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
50.0%
2/4 • 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.
|
|
Nervous system disorders
Aphasia
|
25.0%
1/4 • 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.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • 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.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • 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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • 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.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • 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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
25.0%
1/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
25.0%
1/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
50.0%
2/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • 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.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
50.0%
2/4 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • 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.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • 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.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER