EUCTR2017-000737-31-IT进行中（未招募）1 期
A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of octreotide capsules in patients who previously tolerated and demostrated biochemical control on injectable somatostatin receptor ligands (SRL) treatment - OPTIMA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHIASMA INC.
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult subjects, aged =18 years old at the first Screening visit.
- •2. Patients with active acromegaly, defined as documented evidence of GHsecreting
- •pituitary tumor based on MRI/Pathology report and documented
- •evidence of IGF-1 levels =1.3 × ULN. This needs to be at least 3 months
- •following pituitary surgery in those patients who had prior pituitary surgery.
- •3. Received parenteral SRL monotherapy (octreotide or lanreotide but not
- •pasireotide) for at least 6 months with a stable dose for at least the last three
- •months of therapy.
- •4. Average IGF-1 of 2 assessments obtained during the Screening period is
- •5. Patients able and willing to comply with the requirements of the protocol at
- •the time of Screening.
- •6. Women who are of childbearing potential should use an acceptable method
- •for birth control. Acceptable methods include hormonal contraception (oral
- •contraceptives – as long as on stable dose, patch, implant, and injection),
- •intrauterine devices, or double barrier methods (e.g. vaginal diaphragm/
- •vaginal sponge plus condom, or condom plus spermicidal jelly), sexual
- •abstinence2 or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Women taking oral contraception
- •containing levonorgestrel should either change treatment (at least one month
- •prior to first study medication dose) or use a mechanical barrier method.
- •7. Patients able to understand and sign written informed consent to participate in
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients taking injections of long-acting SRLs off label (unlabeled doses or
- •dosing interval. e.g. 60 or 90mg lanreotide every 8 weeks or 30 mg octreotide
- •every 6 or 8 weeks).
- •2. Patients who previously participated in CH-ACM-01 or OOC-ACM-302
- •(MPOWERED study).
- •3. Symptomatic cholelithiasis.
- •4. Conventional or stereotactic radiotherapy any time in the past
- •5. Undergone pituitary surgery within six months prior to screening or have
- •elective pituitary surgery (or other elective surgery that may affect
- •compliance with protocol or confound study outcomes), planned within the
- •course of the core study.
- •6. High-risk pattern3 of pituitary tumor location on pituitary MRI/Computed
- •tomography (CT) as per medical history or most recent MRI/CT.
- •7. History of unstable angina or acute myocardial infarction within the 12 weeks
- •preceding the screening visit or other clinically significant cardiac disease at
- •the time of screening as judged by the Principal Investigator.
- •8. Any clinically significant uncontrolled nervous system, gastrointestinal (GI),
- •renal, pulmonary, or hepatic concomitant disease that in the Investigator’s
- •opinion would preclude patient participation.
- •9. Evidence of active malignant disease or malignancies diagnosed within the
- •previous one year (except for basal cell carcinoma and uncomplicated – up to
- •stage 1 squamous cell carcinoma that has been excised and cured).
- •10. Known allergy or hypersensitivity to any of the test compounds or materials.
- •11. Known uncontrolled diabetes defined as having a fasting glucose
- •> 150 mg/dL (8.3 mmol/L) or glycosylated hemoglobin (HbA1c) = 8%
- •(patients can be rescreened after diabetes is brought under adequate control,
- •or in case HbA1c < 8%).
- •12. Known defects in visual fields due to optic chiasmal compression or other
- •neurological signs, related to the pituitary tumor mass. Patients withlong-standing (>12 months), fixed, minor defects may be considered on a
- •case-by-case basis after consultation with the medical monitor.
- •13. Female patients who are pregnant or lactating or intending to become
- •pregnant during the study.
- •14. Known history of immunodeficiency (e.g., HIV positive).
- •15. Alanine transaminase (ALT), aspartate aminotransferase (AST) or alkaline
- •phosphatase (ALP) > 3 × ULN or total bilirubin >1.5 × ULN.
- •16. Undergone major surgery/surgical therapy for any cause within four weeks
- •prior to enrollment or planned procedure during the study.
- •17. Known hypothyroidism or hypocortisolism not adequately treated with a
- •stable dose of thyroid or steroid hormone replacement therapy for = 12
- •18. Any condition that may jeopardize study participation (e.g., clinically
- •significant abnormal screening clinical or laboratory finding during
- •screening), the interpretation of study results or may impede the ability to
- •obtain informed consent (e.g., mental condition).
- •19. History of illicit drug or alcohol abuse within five years.
- •20. Intake of an investigational drug within 30 days prior to initiation of study
- •21. Treatment with pegvisomant within 24 weeks before the first screening visit.
- •22. Treatment with dopamine agonists within 12 weeks before the first screening
- •23. Treatment with pasireotide within 24 weeks before the first screening visit.
研究者
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