NL-OMON48177已完成不适用
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LAM-001 in Patients with Lymphangioleiomyomatosis - LAM-001-LAM-CLN03
AI Therapeutics0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient is independently capable of providing informed consent
- •and provides signed informed consent, witnessed by clinic staff, before
- •any study-related assessments or procedures are performed.
- •2. The patient is female and from 18 to 70 years of age, inclusive, with a
- •body mass index from 18.0 to 32.0 kg/m2, inclusive, at the time of
- •screening (Visit 1)
- •a. Patients cannot be pregnant or lactating/breast feeding and must be
- •surgically sterile, postmenopausal (no menses for the previous 12
- •months), or practicing a highly effective method of birth control as
- •described in this protocol. Acceptable methods of birth control are:
- •certain types of hormonal contraception (eg, birth control pill, injection,
- •implant, transdermal patch, or vaginal ring. Progestin-based
- •contraception is allowed. Only low dose estrogen-containing
- •contraceptives are allowed [estrogen dose between 10 and 25 *g]),
- •intrauterine device, tubal ligation (tied tubes), or a partner with a
- •vasectomy. High dose estrogen containing contraceptives are not
- •allowed in this study. Gonadotropin-releasing hormone agonist
- •contraceptives are not allowed in this study.
- •b. Patients must not be planning to become pregnant during the study
- •and agree to use highly effective contraception for at least 90 days after
- •the last dose of study drug.
- •3. The patient has a confirmed diagnosis of LAM as determined by prior
- •clinical evaluation, including compatible chest CT AND one of the
- •a. Biopsy (lung, abdominal mass, lymph node, or kidney) or cytology
- •(from thoracic or abdominal sources that show HMB45 positive staining
- •of spindles/epithelioid cells); OR
- •b. Tuberous sclerosis, angiomyolipoma (diagnosed by prior high
- •resolution chest CT, magnetic resonance imaging, ultrasonography, or
- •biopsy); OR
- •c. Chylous pleural effusion, as verified by thoracentesis (without other
- •etiology); OR
- •d. Serum VEGF-D level *800 pg/mL as part of the previous diagnostic
- •evaluation.
- •4. The patient's pulmonary symptoms and lung function have been
- •stable, as judged by the investigator, over the 3 months before Visit 1.
- •5. The patient has the ability to perform study procedures, including
- •correct use of the RS01 DPI and the spirometry maneuvers.
- •6. The patient agrees to comply with all protocol requirements.
排除标准
- •1. The patient has a pre-bronchodilator FEV1 of *60% of predicted
- •during the screening or baseline visits.
- •2. The patient has used mTOR inhibitors (e.g., rapamycin, everolimus)
- •within 90 days before Visit 1.
- •3. The patient is considered likely to need oral rapamycin or another
- •mTOR inhibitor within 6 months following Visit 1, in the opinion of the
- •investigator.
- •4. The patient has had a pneumothorax within the 2 months before Visit
- •5. The patient is a smoker. Patients will be defined as ex smokers and
- •eligible for participation in the study if they have not consumed tobacco
- •products or other forms of nicotine replacement therapy for at least 6
- •months before Visit 1.
- •6. The patient has a concurrent significant respiratory disease, including
- •any of the following:
- •a. Confirmed or suspected smoking-related chronic obstructive
- •pulmonary disease.
- •b. Other significant respiratory disorder including, but not limited to,
- •pulmonary hypertension, cor pulmonale, pulmonary fibrosis, or
- •bronchiectasis.
- •c. Previous lung transplantation or is active on a transplant list.
- •7. The patient requires regular use of inhaled corticosteroids.
- •8. The patient has significant or uncontrolled disease of any organ
- •system, including psychological illness, that is likely to interfere with the
- •study conduct, patient safety, or the interpretation of study evaluations,
- •as determined by the investigator, including but not limited to the
- •a. Unstable angina, myocardial infarction, previous history of
- •pericarditis, or cerebrovascular event within the past 12 months before
- •screening or uncontrolled hypertension or arrhythmia.
- •b. Uncontrolled dyslipidemia.
- •c. Poorly controlled diabetes mellitus, as evidenced by hemoglobin A1c >8.5%.
- •d. Known history of human immunodeficiency virus or chronic viral
- •hepatitis infection
- •e. Diagnosed with active or untreated latent tuberculous infection or
- •active pulmonary nontuberculous mycobacterial infection. A tuberculosis
- •screening test is not required. Patients who completed a course of
- •antituberculous therapy at least 1 year before screening with no clinical
- •or radiological evidence of disease recurrence may be eligible for
- •f. History of malignancy or treatment for malignancy in the 2 years
- •before screening. Patients who have received curative treatment with
- •resection of nonmelanoma skin cancer or with in situ carcinoma of the
- •cervix may be eligible.
- •9. The patient has a known allergy to rapamycin or has previously
- •discontinued rapamycin due to pulmonary or other safety concerns.
- •10. The patient has a history of severe milk protein allergy (patients with
- •lactose intolerance are eligible).
- •11. The patient requires supplemental oxygen therapy as either longterm
- •oxygen therapy or as required ambulatory oxygen.
- •12. The patient has a significantly abnormal laboratory result at Visit 1,
- •including any of the following:
- •a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
- 另有 8 项未显示
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