Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism

NCTNCT01673646 (opens ClinicalTrials.gov in a new tab)Other idCSOM230C1202
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
33 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
16 Oct 2012
Primary completion
10 Apr 2017
Completion
10 Apr 2017
First posted
28 Aug 2012 (estimated)
Last update posted
16 Sept 2019
Conditions
Acromegaly · Pituitary Gigantism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. Ph 2

    Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism

    NCT01673646

    16 Oct 2012 to 10 Apr 2017

Registry summary

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

To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.

Interventions

  • Pasireotide LARDrug

Arms3

  • Experimental

    Pasireotide LAR 20mg

    Enrolled patients were randomized to 20mg pasireotide LAR.

  • Experimental

    Pasireotide LAR 40mg

    Enrolled patients were randomized to 40mg pasireotide LAR.

  • Experimental

    Pasireotide LAR 60mg

    Enrolled patients were randomized to 60mg pasireotide LAR.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total-group Response Rate at Month 3

    Time frame · Month 3

    Registry description

    Percentage of participants with a reduction of mean growth hormone (GH) levels to \< 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses

Secondary outcomes(17)

  1. Response Rate at Month 3 by Randomized Dose Level

    Time frame · Month 3

    Registry description

    Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3 months in each starting dose.

  2. GH Response at Month 3 by Randomized Dose

    Time frame · Month 3

    Registry description

    Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L at 3 months.

  3. IGF-1 Response at Month 3 by Randomized Dose

    Time frame · Month 3

    Registry description

    Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 3 months.

  4. Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)

    Time frame · Months 3, 6, 9 & 12

    Registry description

    Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months

  5. Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)

    Time frame · Months 3, 6, 9, 12

    Registry description

    This refers to the percentage of participants with a reduction of growth hormone (GH) response rates to \<2.5 ug/L over time.

  6. Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)

    Time frame · Months 3, 6, 9, 12

    Registry description

    This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit.

  7. Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level

    Time frame · Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3

    Registry description

    Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR. Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR.

  8. Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level

    Time frame · Day 28 after injections 1 and 3

    Registry description

    The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).

  9. Change of Tumor Volume From Baseline

    Time frame · Baseline, Months 6 , 12

    Registry description

    This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR.

  10. Change in Mean GH Levels From Baseline

    Time frame · Baseline, Months 2.75, 3, 6, 9, 12, 18, 24

    Registry description

    This shows the change in mean GH levels from baseline in median GH levels by visit.

  11. Change in Ring Size From Baseline

    Time frame · Baseline, Months 3, 6, 9, 12

    Registry description

    Change of clinical signs from baseline: ring size. In Japan, ring sizes are specified using a numerical scale, that only has whole sizes, and does not have simple linear correlation with diameter or circumference. Only numbers are used ranging from 1 to 27. For instance, a ring size of 1 in Japan is equivalent to an inside circumference ring size of 38.86 mm and a ring size of 27 in Japan is equivalent to an inside circumference ring size of 70.15 mm.

  12. Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)

    Time frame · 12 Months (Core phase)

    Registry description

    Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)

  13. Change From Baseline in Prolactin

    Time frame · Baseline, Months 3, 6, 9, 12

    Registry description

    Change in prolactin levels from baseline

  14. Total-group Response Rate by Visit (Extension Phase)

    Time frame · Months 18, 24

    Registry description

    Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) a18 and 24 months of study treatment.

  15. Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)

    Time frame · Months 18, 24

    Registry description

    Percentage of participants with a reduction of mean GH levels to \< 2.5µg/L at 18 and 24 months of study treatment

  16. Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)

    Time frame · Months 18, 24

    Registry description

    Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment

  17. Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)

    Time frame · Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24

    Registry description

    This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase

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 3

Total-group Response Rate at Month 3

GroupValue (Percentage of participants)
Pasireotide LAR - All Participants18.2
Secondary and other outcome results(7)
Secondary outcomeNumber· Month 3

Response Rate at Month 3 by Randomized Dose Level

GroupValue (Percentage of participants)
Pasireotide LAR 20mg9.1
Pasireotide LAR 40mg36.4
Pasireotide LAR 60mg9.1
Secondary outcomeNumber· Month 3

GH Response at Month 3 by Randomized Dose

GroupValue (Percentage of participants)
Pasireotide LAR 20mg27.3
Pasireotide LAR 40mg45.5
Pasireotide LAR 60mg18.2
Secondary outcomeNumber· Month 3

IGF-1 Response at Month 3 by Randomized Dose

GroupValue (Percentage of participants)
Pasireotide LAR 20mg18.2
Pasireotide LAR 40mg45.5
Pasireotide LAR 60mg9.1
Secondary outcomeNumber· Months 3, 6, 9 & 12

Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)

GroupValue (Percentage of participants)
Pasireotide LAR - All Participants18.2
Secondary outcomeNumber· Months 3, 6, 9, 12

Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)

GroupValue (Percenage of participants)
Pasireotide LAR - All Participants30.3
Secondary outcomeNumber· Months 3, 6, 9, 12

Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)

GroupValue (Percentage of participants)
Pasireotide LAR - All Participants24.2
Secondary outcomeMean· Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3

Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level

GroupValue (ng/mL)Spread
Pasireotide LAR 20mg5.363.35
Pasireotide LAR 40mg8.415.26
Pasireotide LAR 60mg10.85.12

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pasireotide LAR 20mgEnrolled patients were randomized to 20mg pasireotide LAR.0 / 113 / 1111 / 11
Pasireotide LAR 40mgEnrolled patients were randomized to 40mg pasireotide LAR.0 / 113 / 1111 / 11
Pasireotide LAR 60mgEnrolled patients were randomized to 60mg pasireotide LAR.0 / 115 / 1111 / 11
Pasireotide LAR - All Participants (All Patieents)Patients who were randomized to the study - regardless of whether they were in the Core or Extension phase.0 / 3311 / 3333 / 33

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: * Patients with medication naïve acromegaly or pituitary gigantism * Patients with inadequately controlled acromegaly or pituitary gigantism Exclusion Criteria: * Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c \>8% * Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment * Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \> 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval

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