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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

NCTNCT02354508 (opens ClinicalTrials.gov in a new tab)Other idCSOM230C2413Other id2014-002630-31Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
123 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
15 countries

Argentina, Belgium, Brazil, Bulgaria, China, Colombia, France, Hungary, Italy, Malaysia, Mexico, Portugal, Romania, Turkey (Türkiye), United Kingdom

Start
31 Mar 2015
Primary completion
8 Jan 2018
Completion
27 Sept 2018
First posted
3 Feb 2015 (estimated)
Last update posted
10 Dec 2019
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 3

    Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

    NCT02354508

    31 Mar 2015 to 27 Sept 2018

Registry summary

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

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.

Interventions

  • Pasireotide LARDrug

Arms1

  • Experimental

    Pasireotide LAR

    Patients who qualify for the core phase of the study will be treated with pasireotide LAR 40 mg initially. Patients not achieving biochemical control can be up-titrated to pasireotide LAR 60 mg.

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall

    Time frame · Week 36

    Registry description

    Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.

  2. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

    Time frame · Week 36

    Registry description

    Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.

  3. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

    Time frame · Wek 36

    Registry description

    Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.

  4. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

    Time frame · Week 36

    Registry description

    Percentage of patients who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment, type of therapy and overall.

  5. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status

    Time frame · Week 36

    Registry description

    Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, overall by baseline diabetic status.

  6. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF

    Time frame · Week 36

    Registry description

    Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)

Secondary outcomes(18)

  1. Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36

    Time frame · Baseline, week 36

    Registry description

    Core phase - Changes in mean GH from study baseline to week 36.

  2. Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36

    Time frame · Baseline, week 36

    Registry description

    Core phase - Changes in standardized IGF-1 from study baseline to week 36.

  3. Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN

    Time frame · Week 12, Week 24, Week 36

    Registry description

    Percentage of participants achieving GH \<1 μg/L and IGF-1 \<ULN at weeks 12 and 24 overall and by GH level at screening.

  4. Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening

    Time frame · Weeks 12, 24 & 36

    Registry description

    Percentage of participants achieving IGF-1 \<ULN at weeks 12, 24 \& 36.

  5. Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status

    Time frame · Weeks 12, 24 & 36

    Registry description

    Core phase - Percentage of patients achieving GH \<1μg/L at week 12, 24, 36 overall and by GH level at screening.

  6. Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

    Time frame · Baseline, Weeks 12, 24 & 36

    Registry description

    Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.

  7. Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms

    Time frame · Weeks 12, 24 & 36

    Registry description

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

  8. Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline

    Time frame · Weeks 12, 24 & 36

    Registry description

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

  9. Core Phase: Change From Baseline in EQ-5D-5L Index Scores

    Time frame · Baseline, Weeks 12, 24 & 36

    Registry description

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

  10. Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment

    Time frame · Baseline, Weeks 12, 24 & 36

    Registry description

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

  11. Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)

    Time frame · Weeks 48, 60 & 72

    Registry description

    Percentage of patients achieving IGF-1 \<ULN at weeks 48, 60 \& 72 for participants with up-titrated to Pasireotide LAR 60 mg mg

  12. Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)

    Time frame · Weeks 48, 60, 72

    Registry description

    Percentage of participants achieving IGF-1 \<ULN at week 46, 60 and 72 overall by baseline diabetic status

  13. Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and by GH Level at Screening

    Time frame · Weeks 48, 60, 72

    Registry description

    Percentage of patients achieving GH \<1 μg/L and IGF-1 \<ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly

  14. Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

    Time frame · Baseline, Weeks 48, 60 & 72

    Registry description

    Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.

  15. Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms

    Time frame · Weeks 48, 60 & 72

    Registry description

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

  16. Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline

    Time frame · Weeks 48, 60 & 72

    Registry description

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

  17. Extension Phase: Change From Baseline in EQ-5D-5L Index Scores

    Time frame · Baseline, Weeks 48, 60 & 72

    Registry description

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

  18. Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment

    Time frame · Baseline, Weeks 48, 60 & 72

    Registry description

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

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· Week 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall

GroupValue (Percentage of participants)
Lanreotide 120 mg14.6
Octreotide 30 mg13.8
Octreotide 40 mg15.1
Pasireotide LAR Overall14.6
Primary outcomeNumber· Week 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

GroupValue (Percentage of participants)
Up-titrated to Pasireotide LAR 60 mg6.7
Primary outcomeNumber· Wek 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

GroupValue (Percentage of participants)
Pasireotide LAR Overall15.7
Primary outcomeNumber· Week 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

GroupValue (Percentage of participants)
Lanreotide 120 mg7.7
Octreotide 30 mg13.0
Octreotide 40 mg20.5
Pasireotide LAR Monotherapy17.1
Pasireotide With Concomitant Medication0.0
Pasireotide LAR Overall14.8
Primary outcomeNumber· Week 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

GroupValue (Percentage of participants)
Up-titrated to Pasireotide LAR 60 mg5.9
Primary outcomeNumber· Week 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status

GroupValue (Percentage of participants)
Pasireotide LAR Overall14.0
Primary outcomeNumber· Week 36

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF

GroupValue (Percentage of participants)
Lanreotide 120 mg14.6
Octreotide 30 mg13.8
Octreotide 40 mg17.0
Pasireotide LAR Overall15.4
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline, week 36

Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36

GroupValue (percentage change)Spread
Lanreotide 120 mg-7.719.51
Octreotide 30 mg-8.524.41
Octreotide 40 mg-2.94.21
Pasireotide LAR Overall-6.017.10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Up-titrated to Pasireotide LAR 60 mgPatients not achieving biochemical control and were up-titrated to pasireotide LAR 60 mg.0 / 926 / 9283 / 92
Pasireotide LAR OverallThis is the sum total of participants in under the previous treatments in the Core phase: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg or who were treated with at least one dose of pasireotide LAR in the extension phase0 / 12312 / 123112 / 123

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2019

3 results

Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs.

Gadelha et al. 2019Frontiers in endocrinologycited by 34

PMID 32117045PMC7008501DOI 10.3389/fendo.2019.00931PUB-32117045

CC BY3 results
Download PDFSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Written informed consent * Male and female patients ≥18 years * Patients with confirmed diagnosis of inadequately controlled acromegaly (mean GH concentration ≥1 μg/L and sex- and age-adjusted IGF-1 \>1.3 x ULN) * Patients treated with octreotide LAR (30 mg or 40 mg) or lanreotide ATG (120 mg) monotherapy for at least 3 months prior to screening Exclusion Criteria: * Concomitant treatment with other medications reducing GH and or IGF-1, unless discontinued 3 months prior to screening * Patients with compression of the optic chiasm requiring surgical intervention * Diabetic patients with HbA1c \>8% at screening * Patients who are hypothyroid and not on adequate replacement therapy * Patients with symptomatic cholelithiasis and acute or chronic pancreatitis * Patients with clinically significant valvular disease * Patients with risk factors for torsade de pointes (TdP) * Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of TdP * Patients with congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function. * Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure * Patients with liver disease or ALT/AST \> 2.0 X ULN, serum bilirubin \>2.0 X ULN - Presence of Hepatitis B surface antigen or Hepatitis C antibody test * Patients with serum creatinine \>2.0 X ULN * Patients with WBC \<3 X 109/L; Hb 90% \< LLN; PLT \<100 X 109/L * Patients with active or suspected acute or chronic uncontrolled infection * Patients who have undergone major surgery/surgical therapy within 4 weeks prior to screening * Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix) * Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time) * History of syncope or family history of idiopathic sudden death * History of immunocompromise, including a positive HIV test result (ELISA and Western blot) * Known hypersensitivity to somatostatin analogues or any other component of pasireotide LAR * Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide * Patients who have given a blood donation (of 400 ml or more) within 2 months before receiving pasireotide * Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing * Patients with any current or prior medical condition interfering with the conduct of the study or the evaluation of the study results * Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study. * Sexually active males unless they use a condom during intercourse while taking drug and for 3 months following last dose of pasireotide * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 3 months following the last dose of pasireotide.

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