NL-OMON48135已完成不适用
A randomized, vehicle-controlled, double-blind, Phase I/IIa, multiple-dose, multiple-cohort, Proof of Concept study in Healthy Volunteers and Patients with Cutaneous T-cell Lymphoma to characterize the safety, efficacy, and pharmacodynamics of topical bimiralisib - topical bimiralisib in HV and patients with CTC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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
- •Healthy volunteers may be included in the study if they meet all the below
- •inclusion criteria:
- •1. Males * 18 years of age
- •2. Fitzpatrick skin type I, II, III or IV
- •3. No clinical significant skin disease in the treatment area(s) and no
- •hypertrophic scarring
- •4. Willing and able to washout and withhold any topical treatment in the
- •treatment area (2 weeks)
- •5. Subjects must understand the investigational nature of this study and sign
- •an independent ethics committee-approved written informed consent form prior to
- •any study related procedure.
- •6. Willing to comply with all study requirements.
- •7. Subjects of reproductive potential must agree to use double contraception
- •from screening until 90 days after discontinuing study treatment and withhold
- •from any sperm donation.Patients may be included in the study if they meet all
- •the below inclusion criteria:
- •1. Males or females * 18 years of age
- •2. Confirmed diagnosis of CTCL (MF): MF stage 1A or 1B (maximum T2N0M0B1) as
- •per Modified ISCL/EORTC revisions (Olsen-2011):
- •a. Confirmed histopathological diagnosis from skin biopsy representative of
- •current disease by pathologist with expertise in cutaneous lymphoma. The date
- •of biopsy should be within the last 5 years. If diagnosis is not confirmed by
- •light microscopic examination, ISCL diagnostic criteria must be used.
- •3. At least 1, 2 and up to 3 target lesions with a (combined) total size of at
- •least 150 cm2
- •4. Willing and able to washout any previous topical treatment (at least 2
- •weeks) and any systemic treatment (at least 4 weeks) prior to first application
- •of topical bimiralisib.
- •5. Otherwise healthy, i.e. absence of clinically significant or unstable
- •disease, with acceptable organ function with lab values within normal range or
- •as specified below:
- •a. eGFR (mCockcroft-Gault) > 30 mL/min.
- •b. AST and ALT <<= 2.5x ULN
- •c. Total bilirubin <<= 1.5x ULN (except patients with Gilbert*s syndrome, who
- •may have total bilirubin <<= 3x ULN)
- •d. Platelet count ><= 100*000 /mm3
- •e. WBC count ><= 1500 /mm3
- •f. ANC count ><= 1500 /mm3
- •g. Fasting blood glucose <<= 125 mg/dL
- •6. Patient must understand the investigational nature of this study and sign an
- •independent ethics committee/ approved written informed consent form prior to
- •any study related procedure.
- •7. Willing to comply with all study requirements.
- •8. Patients of reproductive potential must agree to use double contraception
- •from screening until 90 days after discontinuing study treatment.
- •9. Females who had a menstrual cycle within 2 years of Screening must have a
- •negative serum pregnancy test at Screening and a negative urine pregnancy test
- •on their first dosing
排除标准
- •Healthy volunteers will be excluded from the study if they meet any of the
- •below exclusion criteria:
- •1. Known hypersensitivity to any of the excipients of bimiralisib gel.
- •2. Evidence of any clinically significant active or unstable chronic disease or
- •condition that could interfere with, or for which the treatment of might
- •interfere with, the conduct of the study, or that would pose an unacceptable
- •risk to the subject in the opinion of the investigator (following a detailed
- •medical history, physical examination, vital signs (systolic and diastolic
- •blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram
- •(ECG) at screening or pre-dose). Minor deviations from the normal range may be
- •accepted, if judged by the Investigator to have no clinical relevance.
- •3. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and renal panels, complete blood
- •count, chemistry panel and urinalysis) at screening or pre-dose. In the case of
- •uncertain or questionable results, tests performed during screening may be
- •repeated before randomization to confirm eligibility or judged to be clinically
- •irrelevant for healthy subjects;
- •4. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening, or other known
- •infection requiring antibiotic therapy within the last three months prior to
- •5. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times in the past year;
- •6. Donation of blood or blood loss of >500 mL within 3 months prior to
- •screening or donation of plasma within 14 days
- •7. Any condition that in the opinion of the investigator would complicate or
- •compromise the study or the well-being of the subjectPatients will be excluded
- •from the study if they meet any of the below exclusion criteria:
- •1. Known hypersensitivity to any of the excipients of bimiralisib gel.
- •2. Patients who are on (or will require) any systemic treatment to treat their
- •disease (MF) during the study.
- •3. Concurrent severe and/or uncontrolled medical conditions that would, in the
- •investigator*s judgment, contraindicate patient participation in the clinical
- •study or require concomitant skin-directed or systemic therapy (e.g., active or
- •uncontrolled severe infection, chronic active hepatitis, immuno-compromised,
- •acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial
- •lung disease, etc.).
- •4. Has other active malignancies that require systemic treatment.
- •5. Has a known history of HIV infection or hepatitis (testing not mandatory).
- •6. Pregnant or nursing (lactating) women.
- •7. Has a known history of alcohol or drug abuse within the past 1 year.
- •8. Psychiatric illness, disability or social situation that would compromise
- •the subject*s safety or ability to provide consent, or limit compliance with
- •study requirements.
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