2024-519044-32-00招募中2 期
A Master Protocol Phase I/II Study to Investigate Biomarker‑Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants with Advanced/Recurrent Ovarian Cancer (Ovarian Platform)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 11
- 主要终点
- Safety endpoints will include, but are not limited to, the following: - TEAEs, SAEs, AEs leading to dose modifications, procedure-related AEs. -Changes from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG PS, and physical examinations.
研究概览
简要总结
The primary objective of all substudies in this Master Protocol is safety and tolerability.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant must be of legal or over the legal age of consent in the jurisdiction in which the study is taking place, at the time of screening.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the CSP.
- •Participants must be female at birth.
- •Participants who have histologically or cytologically documented advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, considered to be suitable for treatment with study intervention, as applicable to each substudy.
- •Participants must provide sufficient archival or fresh tumour sample for biomarker testing, as outlined in the respective substudy Laboratory Manual.
- •Measurable disease as per RECIST 1.1 criteria: at least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
- •ECOG PS of 0 to 1, with no deterioration over the previous 2 weeks prior to baseline at screening, and prior to study intervention administration.
- •Adequate organ and bone marrow function as described in substudy protocol.
- •Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Participants must not breastfeed and must not donate or retrieve ova for their own use from screening to substudy-specified duration after the last dose of study intervention.
排除标准
- •Participants are eligible to be included in the study only if all of the following criteria (and all criteria from the respective substudy) apply. However, where specific substudy criteria differ from the master criteria below, the substudy criteria should be applied.
- •Prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix) that required treatment within 2 years prior to screening, whose natural history, in the Investigator’s opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
- •Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s) (as applicable to a substudy).
- •Any concurrent anticancer therapy.
- •Persistent toxicities caused by previous anticancer therapies excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- •Any history of persisting (> 2 weeks) severe pancytopenia due to any cause.
- •Spinal cord compression or brain metastases unless asymptomatic, treated, and stable and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or 2 mg/day of dexamethasone or equivalent for at least 4 weeks prior to start of study intervention. Participants with leptomeningeal carcinomatosis are excluded.
- •Active primary immunodeficiency/active infectious disease(s).
- •Uncontrolled intercurrent illness within the last 12 months, including but not limited to, ongoing or active known infection, active interstitial lung disease, serious chronic GI conditions associated with diarrhoea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticarial, dermatitis, ulceration, or psoriasis) requiring systemic treatment, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
- •Participants with any known predisposition to bleeding.
- •Any cardiac criteria as described in the substudy CSP.
- •Any other cardiovascular diseases as described in the substudy CSP.
结局指标
主要结局
Safety endpoints will include, but are not limited to, the following: - TEAEs, SAEs, AEs leading to dose modifications, procedure-related AEs. -Changes from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG PS, and physical examinations.
Safety endpoints will include, but are not limited to, the following: - TEAEs, SAEs, AEs leading to dose modifications, procedure-related AEs. -Changes from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG PS, and physical examinations.
次要结局
- The primary measure of interest is the estimate of ORR prior to IDS. Confirmation of response is not required.
- The measure of interest is the estimate of confirmed CA125 response rate prior to IDS.
- Plasma concentrations of saruparib and its metabolite(s) if applicable. Report plasma PK parameters, including but not limited to AUC, Cmax and tmax as data allow, of saruparib after single dose and/or multiple doses administration.
研究者
AstraZeneca Clinical Study Information Centre
Scientific
AstraZeneca AB
研究点 (11)
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