Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

NCTNCT00958841Other idCSOM230D2203Other id2008-007348-32Other id2008

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues)

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 118 participants (actual)
Sponsor: Novartis Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 12 countries
United States, Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Russia, Spain, Thailand
Start: Sept 2009
Primary completion: Jun 2015
Completion: Jun 2015
First posted: 13 Aug 2009 (estimated)
Last update posted: 26 Jul 2016 (estimated)
Conditions: Pancreatic Neoplasm · Pituitary Neoplasm · Nelson Syndrome · Ectopic ACTH Syndrome

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201220142016

Ph 2
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
NCT00958841
Sept 2009 to Jun 2015
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Interventions

pasireotide LARDrug

Arms1

Experimental
pasireotide LAR 60mg
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
Time frame · 6 months
Registry description
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.

Secondary outcomes(5)

Percentage of Responders at Month 6 - Individual NETs
Time frame · 6 months
Registry description
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
Time frame · 6 months
Registry description
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Time frame · Baseline, month 6
Registry description
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Time frame · Baseline, month 6
Registry description
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
Time frame · Baseline, month 6
Registry description
Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)

Group	Value (percentage of participants)
Gastrinoma	46.2
VIpoma	0.0
Glucagonoma	0.0

Secondary and other outcome results(5)

Secondary outcomeNumber· 6 months

Percentage of Responders at Month 6 - Individual NETs

Group	Value (percentage of participants)
Gastrinoma	46.2
Prolactinoma	21.6
Nelson's Syndrome	50.0

Secondary outcomeNumber· 6 months

Percentage of Responders With Probability of Success at Month 6 - Individual NETs

Group	Value (Percentage of participants)
Gastrinoma	46.2
Prolactinoma	21.6
Nelson's Syndrome	50.0

Secondary outcomeNumber· Baseline, month 6

PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

Group	Value (Participants)
All PNETS (Gastrinoma)	8

Secondary outcomeNumber· Baseline, month 6

PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

Group	Value (Participants)
All PiNETS (Prolactinoma)	7

Secondary outcomeNumber· Baseline, month 6

Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

Group	Value (Participants)
Nelson's Syndrome	6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pancreatic NETs (PNETs)Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.	–	10 / 25	23 / 25
Pituitary NETs (PiNETs)Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.	–	8 / 72	71 / 72
Ectopic ACTH-secrting Tumors (EAS)Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.	–	5 / 7	7 / 7
Nelsons SyndromeNelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.	–	9 / 14	14 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male and Female Patients at least 18 years old * Patient who have rare tumors of neuroendocrine origin, such as tumors of the: 1. pancreas 2. pituitary glands 3. Nelson syndrome 4. ectopic-ACTH secreting tumor * Patients who have failed standard of care treatment or for whom no standard of care treatment exist * Signed Informed Consent Exclusion Criteria: * Patients with active gallbladder disease * Patients with any ongoing or planned anti-neoplastic or interferon therapy * Poorly controlled diabetes mellitus * Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control Other protocol-defined inclusion/exclusion criteria may apply.

PepBank is a research reference. Talk to a doctor before you use any peptide.