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

NCT01673646 | Completed Phase 2 Results

• 1 other identifier: CSOM230C1202
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 27

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

Keywords

SOM230; Pasireotide; acromegaly; Phase II; growth disorder; gigantism; Pituitary adenoma; pituitary gigantism

Outcome Measures

Primary Outcomes (1)

• Total-group Response Rate at 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

  Month 3

Secondary Outcomes (17)

• Response Rate at Month 3 by Randomized Dose Level

  Month 3

• GH Response at Month 3 by Randomized Dose

  Month 3

• IGF-1 Response at Month 3 by Randomized Dose

  Month 3

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

  Months 3, 6, 9 & 12

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

  Months 3, 6, 9, 12

Study Arms (3)

Pasireotide LAR 20mg

EXPERIMENTAL

Enrolled patients were randomized to 20mg pasireotide LAR.

Drug: Pasireotide LAR

Pasireotide LAR 40mg

EXPERIMENTAL

Enrolled patients were randomized to 40mg pasireotide LAR.

Drug: Pasireotide LAR

Pasireotide LAR 60mg

EXPERIMENTAL

Enrolled patients were randomized to 60mg pasireotide LAR.

Drug: Pasireotide LAR

Interventions

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.

Also known as: SOM230

Pasireotide LAR 20mg; Pasireotide LAR 40mg; Pasireotide LAR 60mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with medication naïve acromegaly or pituitary gigantism
• Patients with inadequately controlled acromegaly or pituitary gigantism

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (27)

Novartis Investigative Site

Nagoya, Aichi-ken, 466 8560, Japan

Location

Novartis Investigative Site

Toyoake, Aichi-ken, 470 1192, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Novartis Investigative Site

Fukushima, Fukushima, 960 1295, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Morioka, Iwate, 020 8505, Japan

Location

Novartis Investigative Site

Kagoshima, Kagoshima-ken, 890 8520, Japan

Location

Novartis Investigative Site

Isehara, Kanagawa, 259-1193, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 211-8510, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 222-0036, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 612-8555, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 530-8480, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, 359 8513, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, 420-8527, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Minato Ku, Tokyo, 105-8470, Japan

Location

Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8666, Japan

Location

Novartis Investigative Site

Chiba, 260 8677, Japan

Location

Novartis Investigative Site

Osaka, 534-0021, Japan

Location

Novartis Investigative Site

Yamagata, 990 9585, Japan

Location

MeSH Terms

Conditions

Acromegaly; Gigantism; Growth Disorders; Pituitary Neoplasms

Interventions

pasireotide

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

After the first 3 months, pasireotide LAR dose could be increased for efficacy or decreased for safety at any time during the study.

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 28, 2012
• Study Start: October 16, 2012
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-07

Locations

JP (27)