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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

NCTNCT00690430 (opens ClinicalTrials.gov in a new tab)Other idCSOM230C2303Other id2007-000739-25
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
186 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Randomized · Triple masking
Countries
16 countries

United States, Argentina, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Norway, Poland, Singapore, Spain, Sweden, United Kingdom

Start
Apr 2008
Primary completion
Apr 2012
Completion
Apr 2012
First posted
4 Jun 2008 (estimated)
Last update posted
30 Jul 2013 (estimated)
Conditions
Symptomatic Refractory Resistant Carcinoid Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 3

    Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease

    NCT00690430

    Apr 2008 to Apr 2012

Registry summary

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

The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

Interventions

  • PasireotideDrug
  • OctreotideDrug

Arms2

  • Active comparator

    Pasireotide LAR

    Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.

  • Active comparator

    Octreotide LAR

    Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.

    Time frame · Month 6

    Registry description

    Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): \<4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of \<5 flushing episodes. (CBRC) \<4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of \<4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.

Secondary outcomes(9)

  1. Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.

    Time frame · 6 months

    Registry description

    Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.

  2. Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.

    Time frame · 6 months

    Registry description

    Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.

  3. Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.

    Time frame · Month 6

  4. Objective Tumor Response Rate Assessed by Investigator

    Time frame · Month 6

    Registry description

    Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

  5. Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria

    Time frame · Month 6

    Registry description

    Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.

  6. Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire

    Time frame · Month 6

  7. Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression

    Time frame · Month 6

  8. Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response

    Time frame · Month 6

  9. Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements

    Time frame · 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· Month 6

Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.

GroupValue (Percentage of Participants)
Pasireotide LAR13.5
Octreotide LAR28.2
Secondary and other outcome results(7)
Secondary outcomeMean· 6 months

Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.

GroupValue (Percentage of Episodes)Spread
Pasireotide LAR-23.524.28
Octreotide LAR-38.428.74
Secondary outcomeMean· 6 months

Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.

GroupValue (Percentage of Episodes)Spread
Pasireotide LAR-41.041.06
Octreotide LAR-52.832.18
Secondary outcome· Month 6

Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.

GroupValue
Pasireotide LARnot posted
Octreotide LARnot posted
Secondary outcomeNumber· Month 6

Objective Tumor Response Rate Assessed by Investigator

GroupValue (Percentage of Participants)
Pasireotide LAR2.0
Octreotide LAR3.8
Secondary outcomeNumber· Month 6

Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria

GroupValue (Percentage of participants)
Pasireotide LAR62.7
Octreotide LAR46.2
Secondary outcome· Month 6

Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire

GroupValue
Pasireotide LARnot posted
Octreotide LARnot posted
Secondary outcome· Month 6

Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression

GroupValue
Pasireotide LARnot posted
Octreotide LARnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pasireotide LARPatients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.–15 / 5350 / 53
Octreotide LARPatients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.–19 / 5748 / 57
Extension Phase Pasireotide LARPatients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.–9 / 2019 / 20
Extension Phase Octreotide LARPatients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.–2 / 65 / 6
Crossover to Pasireotide LARAfter 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.–7 / 1512 / 15

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 or female patients aged 18 or greater * Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues. * Female patients of child bearing potential must have a negative pregnancy test at baseline. * Patients for whom written informed consent to participate in the study has been obtained. Exclusion criteria: * Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization * Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C \> 8% * Patients with symptomatic cholelithiasis * Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means. Other protocol-defined inclusion/exclusion criteria may apply

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