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NCT01673646 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-09-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Total-group Response Rate at Month 3

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outcome · POSTED

Response Rate at Month 3 by Randomized Dose Level

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outcome · POSTED

GH Response at Month 3 by Randomized Dose

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outcome · POSTED

IGF-1 Response at Month 3 by Randomized Dose

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Change of Tumor Volume From Baseline

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outcome · POSTED

Change in Mean GH Levels From Baseline

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outcome · POSTED

Change in Ring Size From Baseline

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline in Prolactin

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outcome · POSTED

Total-group Response Rate by Visit (Extension Phase)

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Enrolled patients were randomized to 20mg pasireotide LAR.
    intervention Names
    1. Drug: Pasireotide LAR
    label
    Pasireotide LAR 20mg
    type
    EXPERIMENTAL
  2. description
    Enrolled patients were randomized to 40mg pasireotide LAR.
    intervention Names
    1. Drug: Pasireotide LAR
    label
    Pasireotide LAR 40mg
    type
    EXPERIMENTAL
  3. description
    Enrolled patients were randomized to 60mg pasireotide LAR.
    intervention Names
    1. Drug: Pasireotide LAR
    label
    Pasireotide LAR 60mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Pasireotide LAR 20mg
    2. Pasireotide LAR 40mg
    3. Pasireotide LAR 60mg
    description
    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.
    name
    Pasireotide LAR
    other Names
    1. SOM230
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
33
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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
    measure
    Total-group Response Rate at Month 3
    time Frame
    Month 3
secondary Outcomes
  1. 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.
    measure
    Response Rate at Month 3 by Randomized Dose Level
    time Frame
    Month 3
  2. description
    Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L at 3 months.
    measure
    GH Response at Month 3 by Randomized Dose
    time Frame
    Month 3
  3. description
    Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 3 months.
    measure
    IGF-1 Response at Month 3 by Randomized Dose
    time Frame
    Month 3
  4. 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
    measure
    Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
    time Frame
    Months 3, 6, 9 & 12
  5. description
    This refers to the percentage of participants with a reduction of growth hormone (GH) response rates to \<2.5 ug/L over time.
    measure
    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
  6. 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.
    measure
    Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
    time Frame
    Months 3, 6, 9, 12
  7. 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.
    measure
    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
  8. description
    The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).
    measure
    Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
    time Frame
    Day 28 after injections 1 and 3
  9. 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.
    measure
    Change of Tumor Volume From Baseline
    time Frame
    Baseline, Months 6 , 12
  10. description
    This shows the change in mean GH levels from baseline in median GH levels by visit.
    measure
    Change in Mean GH Levels From Baseline
    time Frame
    Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
  11. 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.
    measure
    Change in Ring Size From Baseline
    time Frame
    Baseline, Months 3, 6, 9, 12
  12. description
    Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)
    measure
    Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
    time Frame
    12 Months (Core phase)
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      primary nct id
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      source record id
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      source file sha256
      3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
      payload sha256
      58821a187255a5ada993b080123f4825bb86945db2c5bce4d0d97a476c9356ca
      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-ed9e5e63ccc8970f3b4d
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT01673646
        end
        11
        exact text
        NCT01673646
        start
        0
      offset unit
      unicode_code_points
      query cond
      Pituitary Tumors
      query disease state id
      ds-pituitary-tumors
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pituitary-tumors-000.json
      source file sha256
      3ef78ce4ecba793eb2b9932bd51babe9d6d7cee15aba0d82d9e98002353b720a
      source json pointer
      /studies/27/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      91279e40f05894018f1f19c78fdf25e5cc0f9600ff4d21a216d2157988139b63

    Preserved source evidence · Not medical advice