EUCTR2011-002912-10-GB进行中（未招募）1 期
Efficacy and safety of oral Octreolin™ in patients with acromegaly who are currently receiving parenteral somatostatin analogs - Efficacy and Safety of Octreolin for Acromegaly
Chiasma, Inc0 个研究点目标入组 155 人开始时间: 2011年8月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 155
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
入选标准
- •1. Adult subjects, aged 18 to 75 years old, inclusive, at screening visit
- •2. Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving regular parenteral injections at a stable dose for at least 3 months and are considered complete responders or at least partial responders to a somatostatin analog:
- •o Eligible somatostatin analogs includes: octreotide (sc and LAR), lanreotide (LA, Autogel or Depot)
- •o Complete response is defined as: IGF-1 normalized for age and integrated GH response over 2 hours < 2.5 ng/mL
- •o Partial response is defined as: IGF-1 < 30% above level normalized for age (i.e., < 1.3 times the upper limit of normal) and integrated GH response over 2 hours < 2.5 ng/mL
- •o Age-normalized IGF-1 will be considered the 2.5th to 97.5th percentile range for the central reference laboratory. Local laboratory values will not be used to qualify patients for the study
- •o Subjects taking regular injections of somatostatin analogs less frequently than monthly will not be eligible
- •o Subjects taking injections of octreotide on an as-needed basis to treat headaches will not be eligible
- •3. Subjects receiving appropriate stable doses of hormone replacement therapy for =3 months
- •4. Subjects able and willing to comply with the requirements of the protocol
- •5. Subjects able to swallow capsules
- •6. Subjects able to understand and sign written informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Symptomatic cholelithiasis
- •2. Received pituitary radiotherapy within ten years prior to screening
- •3. Undergone pituitary surgery within the prior 6 months
- •4. High-risk pattern of pituitary tumor location on pituitary MRI
- •5. Clinically significant GI, renal or hepatic disease as determined by the Principal Investigator. Conditions significantly affecting gastric acidity or emptying will typically exclude patients (e.g., bariatric surgery). Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use of H2-antagonists will exclude subjects
- •6. Known allergy or hypersensitivity to any of the test compounds or materials.
- •7. Life expectancy of less than 2 years
- •8. Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dL (8.3 mmol/L) or HbA1c = 8% (Patients can be rescreened after diabetes is brought under adequate control); For Afro-Caribbeans, Fructosamine (marker of glucose tolerance) level of >288 mmol/L
- •9. Defects in visual fields due to optic chiasmal compression or other neurological signs, related to the pituitary tumor mass. Subjects with long-standing (>12 months), fixed, minor defects may be considered on a case-by-case basis after consultation with the Medical Monitor.
- •10. Active, clinically significant cardiac disease, including sustained arrhythmia, at time of screening
- •11. History of unstable angina or acute myocardial infarction within the three months preceding study screening
- •12. Female patients who are pregnant or lactating
- •13. Female patients who are of childbearing potential with a positive pregnancy test at screening or baseline or who not practicing an acceptable method for birth control. Acceptable methods include intrauterine devices, mechanical methods (e.g., vaginal diaphragm, vaginal sponge or condom with spermicidal jelly), or a vasectomized partner. Oral contraceptives are not permitted. Women may be surgically sterile or at least 1 year post-last menstrual period
- •14. History of immunocompromise, including a positive HIV test result (ELISA and Western blot)
- •15. Undergone major surgery/surgical therapy for any cause within 4 weeks prior to enrollment
- •16. Hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or steroid hormone replacement therapy for = 3 months
- •17. History of alcohol or drug abuse
- •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. Intake of an investigational drug within 30 days before patient inclusion in this study
- •20. Current or recent (< 3 months) therapy with pegvisomant
- •21. Current or recent (< 2 months) therapy with cabergoline
研究者
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