Status
Completed
Phase
Phase 2
Enrollment
33
Locations
27
Results
Posted
Publications
0
Study 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.
Interventions
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.
Timeline
First posted
Aug 28, 2012
Study start
Oct 16, 2012
Primary completion
Apr 10, 2017
Study completion
Apr 10, 2017
Results posted
Sep 16, 2019
Registry updated
Sep 16, 2019
Outcomes
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
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.
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.
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.
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
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.
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.
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.
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).
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.
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.
Eligibility
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
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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