TriangleNCT01794793 · STUDY IN CONTEXT
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- trial label
- Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- outcome key
- om-0000
- source section id
- NCT01794793-om-0000
- source outcome index
- 0
- endpoint
- Incidence of Adverse Events to Evaluate Long Term Safety Data
- endpoint definition
- Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
- time origin
- Baseline up to approximately 10 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Safety Set included all patients who received at least one dose of study medication (pasireotide) after enrolling into the roll-over protocol
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- outcome key
- om-0001
- source section id
- NCT01794793-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Patients With Clinical Benefit as Assessed by the Investigator
- endpoint definition
- Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.
- time origin
- Baseline up to approximately 10 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Number of patients judged by the investigator to be clinically benefitting from treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Subjects
- regimen
- Patients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis
- analyzed count
- 337
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01794793-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pasireotide Subcutaneous
- regimen
- 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01794793-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Pasireotide Long Acting Release (LAR)
- regimen
- 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days i.m. Strength is dependent on parent study guidelines
- analyzed count
- 299
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01794793-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT01794793
- harm key
- EG000
- source section id
- NCT01794793-ae
- event group key
- EG000
- event group label
- All Subjects
- serious affected
- 91
- serious at risk
- 337
- other affected
- 220
- other at risk
- 337
- frequency threshold
- 5
- collection period
- Pasireotide s.c.: From start of study treatment up to 1 month after study treatment discontinuation (about 10 years) Pasireotide LAR: From start of study treatment up to 3 months after study treatment discontinuation (about 10 years)
- event definition
- Safety was monitored by collecting AEs/SAEs at every visit and throughout the study period (not limited to patient contact times) according to the sponsor's routine safety monitoring practices. Patients might have safety assessments performed by the clinic's local laboratory as per investigators judgement and standard of care at any time during the study period.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice