Clinical Trial: Efficacy and Safety of Pasireotide LAR in Japanese Patients With Acromegaly or Pituitary Gigantism
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Growth Hormone (GH) and glucagon-like peptide-1 (IGF-1) [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- GH and IGF-1 [ Time Frame: 3 months ]Assess the effect of each starting dose 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
- Profile of Pharmacokinetics [ Time Frame: predose, day2, day15, day22 and every 28days up to 12 months ]Assess Ctrough, Cmax and accumulation ratio of pasireotide LAR 20 mg, 40 mg and 60 mg
- Number of patients with Adverse Events as a Measure of safety and tolerability [ Time Frame: every 28days up to 24 months ]Assess the tolerability and safety profile of pasireotide LAR at 3 months and during and after the 24- month study treatment using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale
- GH [ Time Frame: Baeline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 motnhs ]Assess the effect of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L at 3, 6, 9, 12, 18 and 24 months of study treatment and the change of mean GH level from baseline
- IGF-1 [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months and 24 months ]Assess the effect of pasireotide LAR on the normalization of IGF-1 at 3, 6, 9, 12, 18, 24 months of study treatment
- Tumor volume [ Time Frame: Baseline, 6 months and 12 months ]Assess the effect of pasireotide LAR on the change of tumor volume at 6and 12 months of study treatment
- Change of clinical signs from baseline [ Time Frame: Baseline, every 3months up to 12 months ]Clinical signs include ring size, headache, fatigue, perspiration, paresthesias, osteoarthralgia
- Prolactin (PRL) [ Time Frame: Baseline, every 3 months up to 12 months ]Assess the effect of pasireotide LAR on the change of PRL level from baseline
- Profile of Pharmacokinetic/Pharmacodynamic [ Time Frame: Day1, Day2, Day15, Day22, every 28days up to 6 months ]Assess the relationship between pasireotide plasma concentration and GH/IGF-1
- GH and IGF-1 [ Time Frame: 6months, 9 months, 12 months 18 months and 12 months ]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 6, 9, 12, 18, 24 months of study treatment.
Original Secondary Outcome:
- GH and IGF-1 [ Time Frame: 3 months ]Assess the effect of each starting dose 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
- Profile of Pharmacokinetics [ Time Frame: predose, day2, day15, day22 and every 28days up to 12 months ]Assess Ctrough, Cmax and accumulation ratio of pasireotide LAR 20 mg, 40 mg and 60 mg
- Number of patients with Adverse Events as a Measure of safety and tolerability [ Time Frame: every 28days up to 24 months ]Assess the tolerability and safety profile of pasireotide LAR at 3 months and during and after the 24- month study treatment using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale
- GH [ Time Frame: Baeline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 motnhs ]Assess the effect of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L at 3, 6, 9, 12, 18 and 24 months of study treatment and the change of mean GH level from baseline
- IGF-1 [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months and 24 months ]Assess the effect of pasireotide LAR on the normalization of IGF-1 at 3, 6, 9, 12, 18, 24 months of study treatment
- Tumor volume [ Time Frame: Baseline, 6 months and 12 months ]Assess the effect of pasireotide LAR on the change of tumor volume at 6and 12 months of study treatment
- Change of clinical signs from baseline [ Time Frame: Baseline, every 3months up to 12 months ]Clinical signs include ring size, headache, fatigue, perspiration, paresthesias, osteoarthralgia
- Prolactin (PRL) [ Time Frame: Baseline, every 3 months up to 12 months ]Assess the effect of pasireotide LAR on the cahge of PRL level from baseline
- Profile of Pharmacokinetic/Pharmacodynamic [ Time Frame: Day1, Day2, Day15, Day22, every 28days up to 6 months ]Assess the relationship between pasideotide plasma concentration and GH/IGF-1
- GH and IGF-1 [ Time Frame: 6months, 9 months, 12 months 18 months and 12 months ]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 6, 9, 12, 18, 24 months of study treatment.
Information By: Novartis
Dates:
Date Received: August 16, 2012
Date Started: October 16, 2012
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017