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

NCT ID: NCT01673646

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-16
• Study Completion Date: 2017-04-10

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.

Conditions

Acromegaly; Pituitary Gigantism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pasireotide LAR 20mg

Enrolled patients were randomized to 20mg pasireotide LAR.

Group Type: EXPERIMENTAL

Pasireotide LAR

Intervention Type: 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.

Pasireotide LAR 40mg

Enrolled patients were randomized to 40mg pasireotide LAR.

Group Type: EXPERIMENTAL

Pasireotide LAR

Intervention Type: 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.

Pasireotide LAR 60mg

Enrolled patients were randomized to 60mg pasireotide LAR.

Group Type: EXPERIMENTAL

Pasireotide LAR

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SOM230

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Toyoake, Aichi-ken, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Novartis Investigative Site

Fukushima, Fukushima, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Morioka, Iwate, Japan

Novartis Investigative Site

Kagoshima, Kagoshima-ken, Japan

Novartis Investigative Site

Isehara, Kanagawa, Japan

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Kyoto, Kyoto, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Tokorozawa, Saitama, Japan

Novartis Investigative Site

Shizuoka, Shizuoka, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Itabashi-ku, Tokyo, Japan

Novartis Investigative Site

Minato Ku, Tokyo, Japan

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Novartis Investigative Site

Chiba, , Japan

Novartis Investigative Site

Osaka, , Japan

Novartis Investigative Site

Yamagata, , Japan

Countries

Japan

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CSOM230C1202

Identifier Type: -

Identifier Source: org_study_id