Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) Per Local Radiological Review	Once 80 PFS events had occurred aproximately after 24 months	PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Secondary	Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR	Once 80 PFS events had occurred	Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range.
Secondary	Objective Response Rate (ORR) as Per Radiology Review	Once 80 PFS events had occurred	Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline.
Secondary	Duration of Response (DoR)	Once 80 PFS events had occurred	80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.
Secondary	Overall Survival (OS) Using Kaplan Meier Method	Once 80 PFS events had occurred	Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact.
Secondary	PFS and the Predictive Probability of Success in Phase III	Once 105 PFS events had occurred occurred	105 PFS events expected after approximately 36 months
Secondary	Disease Control Rate (DCR) as Per Radiology Review	Once 80 PFS events had occurred	Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD.
Secondary	Summary of Pharmacokinetics (PK) for Everolimus for AUClast	Cycle 2 Day 1
Secondary	Summary of Pharmacokinetics (PK) for Everolimus for CL/F	Cycle 2 Day 1
Secondary	Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin	Cycle 2 Day 1
Secondary	Summary of Pharmacokinetics (PK) for Everolimus for Tmax	Cycle 2 Day 1
Secondary	Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg	Cycle 1 Day 21, Cycle 2 Day 29

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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