Overview

This trial is active, not recruiting.

Condition acromegaly, pituitary gigantism
Treatment som230lar
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date October 2012
End date February 2017
Trial size 33 participants
Trial identifier NCT01673646, CSOM230C1202

Summary

To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective is 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 IGF-1 at 3 months of study treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
10 enrolled patients will be randomized to 20mg pasireotide LAR.
som230lar
Intramuscular administration of pasireotide LAR will be repeated every month (1 month = 28 days) for 12 months in core phase. It is 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 is permitted to reduce the next lower dosage level at any time.
(Experimental)
10 enrolled patients will be randomized to 40mg pasireotide LAR.
som230lar
Intramuscular administration of pasireotide LAR will be repeated every month (1 month = 28 days) for 12 months in core phase. It is 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 is permitted to reduce the next lower dosage level at any time.
(Experimental)
10 enrolled patients will be randomized to 60mg pasireotide LAR.
som230lar
Intramuscular administration of pasireotide LAR will be repeated every month (1 month = 28 days) for 12 months in core phase. It is 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 is permitted to reduce the next lower dosage level at any time.

Primary Outcomes

Measure
Growth Hormone (GH) and glucagon-like peptide-1 (IGF-1)
time frame: 3 months

Secondary Outcomes

Measure
GH and IGF-1
time frame: 3 months
Profile of Pharmacokinetics
time frame: predose, day2, day15, day22 and every 28days up to 12 months
Number of patients with Adverse Events as a Measure of safety and tolerability
time frame: every 28days up to 24 months
GH
time frame: Baeline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 motnhs
IGF-1
time frame: 3 months, 6 months, 9 months, 12 months, 18 months and 24 months
Tumor volume
time frame: Baseline, 6 months and 12 months
Change of clinical signs from baseline
time frame: Baseline, every 3months up to 12 months
Prolactin (PRL)
time frame: Baseline, every 3 months up to 12 months
Profile of Pharmacokinetic/Pharmacodynamic
time frame: Day1, Day2, Day15, Day22, every 28days up to 6 months
GH and IGF-1
time frame: 6months, 9 months, 12 months 18 months and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Novartis.