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Trial record 1 of 4 for:
"Gigantism"
Efficacy and Safety of Pasireotide LAR in Japanese Patients With Acromegaly or Pituitary Gigantism
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01673646
First received: August 16, 2012
Last updated: April 26, 2017
Last verified: April 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Acromegaly, Pituitary Gigantism | Drug: SOM230LAR | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Pituitary Disorders
Drug Information available for:
Pasireotide
U.S. FDA Resources
Further study details as provided by Novartis ( Novartis Pharmaceuticals ):
Primary Outcome Measures:
- Growth Hormone (GH) and glucagon-like peptide-1 (IGF-1) [ Time Frame: 3 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 3 months of study treatment.
Secondary Outcome Measures:
- 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.
| Enrollment: | 33 |
| Actual Study Start Date: | October 16, 2012 |
| Study Completion Date: | April 10, 2017 |
| Primary Completion Date: | April 10, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SOM230LAR 20mg
10 enrolled patients will be randomized to 20mg pasireotide LAR.
|
Drug: 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: SOM230LAR 40mg
10 enrolled patients will be randomized to 40mg pasireotide LAR.
|
Drug: 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: SOM230LAR 60mg
10 enrolled patients will be randomized to 60mg pasireotide LAR.
|
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673646
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673646
Locations
| Japan | |
| Novartis Investigative Site | |
| Nagoya-city, Aichi, Japan, 466-8560 | |
| Novartis Investigative Site | |
| Toyoake-city, Aichi, Japan, 470-1192 | |
| Novartis Investigative Site | |
| Chiba-city, Chiba, Japan, 260-8677 | |
| Novartis Investigative Site | |
| Fukuoka city, Fukuoka, Japan, 812-8582 | |
| Novartis Investigative Site | |
| Kitakyushu-city, Fukuoka, Japan, 807-8556 | |
| Novartis Investigative Site | |
| Fukushima-city, Fukushima, Japan, 960-1295 | |
| Novartis Investigative Site | |
| Sapporo-city, Hokkaido, Japan, 060-8648 | |
| Novartis Investigative Site | |
| Kobe-city, Hyogo, Japan, 650-0017 | |
| Novartis Investigative Site | |
| Morioka-city, Iwate, Japan, 020-8505 | |
| Novartis Investigative Site | |
| Kagoshima-city, Kagoshima, Japan, 890-8520 | |
| Novartis Investigative Site | |
| Isehara-city, Kanagawa, Japan, 259-1193 | |
| Novartis Investigative Site | |
| Kawasaki, Kanagawa, Japan, 211-8510 | |
| Novartis Investigative Site | |
| Yokohama, Kanagawa, Japan, 222-0036 | |
| Novartis Investigative Site | |
| Kyoto-city, Kyoto, Japan, 612-8555 | |
| Novartis Investigative Site | |
| Sendai-city, Miyagi, Japan, 980-8574 | |
| Novartis Investigative Site | |
| Okayama-city, Okayama, Japan, 700-8558 | |
| Novartis Investigative Site | |
| Osaka-city, Osaka, Japan, 530-8480 | |
| Novartis Investigative Site | |
| Osaka-city, Osaka, Japan, 534-0021 | |
| Novartis Investigative Site | |
| Suita-city, Osaka, Japan, 565-0871 | |
| Novartis Investigative Site | |
| Tokorozawa-city, Saitama, Japan, 359-8513 | |
| Novartis Investigative Site | |
| Bunkyo-ku, Tokyo, Japan, 113-8603 | |
| Novartis Investigative Site | |
| Bunkyo-ku, Tokyo, Japan, 113-8655 | |
| Novartis Investigative Site | |
| Itabashi-ku, Tokyo, Japan, 173-8610 | |
| Novartis Investigative Site | |
| Minato-ku, Tokyo, Japan, 105-8470 | |
| Novartis Investigative Site | |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Novartis Investigative Site | |
| Shizuoka, Japan, 420-8527 | |
| Novartis Investigative Site | |
| Yamagata, Japan, 990-9585 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01673646 History of Changes |
| Other Study ID Numbers: |
CSOM230C1202 |
| Study First Received: | August 16, 2012 |
| Last Updated: | April 26, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
SOM230, Pasireotide, acromegaly, Phase II |
Additional relevant MeSH terms:
|
Gigantism Pituitary Diseases Acromegaly Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Endocrine System Diseases Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Bone Diseases, Developmental |
ClinicalTrials.gov processed this record on July 13, 2017