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

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ClinicalTrials.gov Identifier: NCT01673646
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acromegaly Pituitary Gigantism Drug: Pasireotide LAR Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 16, 2012
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pasireotide LAR 20mg
Enrolled patients were randomized to 20mg pasireotide LAR.
 Drug: Pasireotide LAR
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 Name: SOM230
Experimental: Pasireotide LAR 40mg
Enrolled patients were randomized to 40mg pasireotide LAR.
 Drug: Pasireotide LAR
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 Name: SOM230
Experimental: Pasireotide LAR 60mg
Enrolled patients were randomized to 60mg pasireotide LAR.
 Drug: Pasireotide LAR
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 Name: SOM230


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673646


Locations
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Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 466 8560
Novartis Investigative Site
Toyoake city, Aichi, Japan, 470 1192
Novartis Investigative Site
Fukuoka city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan, 807-8556
Novartis Investigative Site
Fukushima city, Fukushima, Japan, 960 1295
Novartis Investigative Site
Sapporo city, Hokkaido, Japan, 060 8648
Novartis Investigative Site
Kobe-shi, Hyogo, Japan, 650-0017
Novartis Investigative Site
Morioka, Iwate, Japan, 020 8505
Novartis Investigative Site
Kagoshima city, Kagoshima, Japan, 890 8520
Novartis Investigative Site
Isehara, Kanagawa, Japan, 259-1193
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 211-8510
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 222-0036
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 612-8555
Novartis Investigative Site
Sendai city, Miyagi, Japan, 980 8574
Novartis Investigative Site
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site
Osaka-city, Osaka, Japan, 530-8480
Novartis Investigative Site
Suita city, Osaka, Japan, 565 0871
Novartis Investigative Site
Tokorozawa city, Saitama, Japan, 359 8513
Novartis Investigative Site
Shizuoka-city, Shizuoka, Japan, 420-8527
Novartis Investigative Site
Bunkyo ku, Tokyo, Japan, 113 8655
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Novartis Investigative Site
Minato ku, Tokyo, Japan, 105-8470
Novartis Investigative Site
Shinjuku ku, Tokyo, Japan, 162 8666
Novartis Investigative Site
Chiba, Japan, 260 8677
Novartis Investigative Site
Osaka, Japan, 534-0021
Novartis Investigative Site
Yamagata, Japan, 990 9585
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] January 25, 2017
Study Protocol  [PDF] July 11, 2014

More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01673646    
Other Study ID Numbers: CSOM230C1202
First Posted: August 28, 2012    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
SOM230
Pasireotide
acromegaly
Phase II
 growth disorder
gigantism
Pituitary adenoma
pituitary gigantism
Additional relevant MeSH terms:
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Acromegaly
Gigantism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Endocrine
 Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Bone Diseases, Developmental
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs