Skip to main content
OpenTrials
Completed

NCT Number: NCT01673646

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gigantism Growth Disorders Hyperpituitarism Hypothalamic Diseases Hypothalamic Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Pituitary Gigantism Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pasireotide LAR

Drug

Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 > ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.

Other names: SOM230

Primary outcomes

  1. Total-group Response Rate at Month 3

    Time frame: Month 3

    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

  1. Response Rate at Month 3 by Randomized Dose Level

    Time frame: Month 3

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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)

    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

    Change in prolactin levels from baseline

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

    Time frame: Months 18, 24

    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

    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

    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

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2012
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.