Clinical trial NCT01673646: Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acromegaly
Pituitary Gigantism
Keywords: SOM230
Pasireotide
acromegaly
Phase II
growth disorder
gigantism
Pituitary adenoma
pituitary gigantism
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total-group Response Rate at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: Response Rate at Month 3 by Randomized Dose Level
timeFrame: Month 3
measure: GH Response at Month 3 by Randomized Dose
timeFrame: Month 3
measure: IGF-1 Response at Month 3 by Randomized Dose
timeFrame: Month 3
measure: Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
timeFrame: Months 3, 6, 9 & 12
measure: Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
timeFrame: Months 3, 6, 9, 12
measure: Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level
timeFrame: Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3
measure: Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
timeFrame: Day 28 after injections 1 and 3
measure: Change of Tumor Volume From Baseline
timeFrame: Baseline, Months 6 , 12
measure: Change in Mean GH Levels From Baseline
timeFrame: Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
measure: Change in Ring Size From Baseline
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
timeFrame: 12 Months (Core phase)
measure: Change From Baseline in Prolactin
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Total-group Response Rate by Visit (Extension Phase)
timeFrame: Months 18, 24
measure: Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)
timeFrame: Months 18, 24
measure: Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)
timeFrame: Months 18, 24
measure: Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)
timeFrame: Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyoake city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukushima city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kagoshima city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Isehara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Tokorozawa city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Shizuoka-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: