A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain MolecularAlterations (PLANETTE)

AstraZeneca AB0 个研究点目标入组 52 人开始时间: 2020年11月2日最近更新: 2024年9月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 52

研究概览入排标准研究者记录与标识符相似试验

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

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1 Capable of giving signed informed consent as described in protocol
•2 Provision of written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
•3 Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
•4 Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
•5 Participant is willing and able to comply with the study protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
•6 Participant must be able to swallow tablets whole.
•Please also refer to the relevant module for specific criteria applicable to each cohort.
•Where criteria are more stringent in the module rather than the core, the investigator should adhere to the module criteria
•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 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•1 Persistent toxicities (> CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.
•2 History of another primary malignancy except for:
•? Malignancy treated with curative intent and with no known active disease = 2 years before the first dose of study drug and of low potential risk for recurrence
•? Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•? Adequately treated carcinoma in situ without evidence of disease
•? Localised non-invasive primary under surveillance
•3 Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD, severe Parkinson’s disease, active inflammatory bowel disease) or psychiatric condition (screening for chronic disease is not required).
•4 Participants with a known hypersensitivity to study interventions or any of the excipients of the products.
•5 Major surgery within 2 weeks of starting study intervention: participants must have recovered from any effects of any major surgery.
•6 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
•7 Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
•8 Previous enrolment in the present study.
•9 Participants with gastrointestinal disorders likely to interfere with absorption of the study intervention.
•10 Pregnant (confirmed with positive pregnancy test) or breast feeding women.
•In addition, the following are considered criteria for exclusion from the optional exploratory host genetic research:
•11 Previous allogenic bone marrow transplant.
•12 Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
•Please also refer to the relevant module for specific criteria applicable to each cohort. Where criteria are more stringent in the module rather than the core, the investigator should adhere to the module criteria

研究者

发起方

AstraZeneca AB

相似试验

进行中（未招募）

1 期

A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced CancerAdvanced Cancer Whose Tumours Contain Molecular AlterationsMedDRA version: 21.0Level: LLTClassification code: 10048683Term: Advanced cancer Class: 10029104

CTIS2024-515102-12-00AstraZeneca AB2

进行中（未招募）

1 期

A phase 2 trial to study safety and efficacy of Capivasertib in patients with blood cancer where disease or cancer cell grows after a period of remission or response to treatment does not last very longRelapsed or Refractory B-cell Non-Hodgkin LymphomaMedDRA version: 24.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2021-000870-27-DKAstraZeneca AB272

已完成

2 期

2024-516386-36-00AstraZeneca AB1

进行中（未招募）

1 期

A phase 2 trial to study safety and efficacy of Capivasertib in patients with blood cancer where disease or cancer cell grows after a period of remission or response to treatment does not last very longRelapsed or Refractory B-cell Non-Hodgkin LymphomaMedDRA version: 20.0Level: PTClassification code: 10061275Term: Mantle cell lymphoma Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10076596Term: Marginal zone lymphoma Class: 100000004864MedDRA version: 24.0Level: LLTClassification code: 10067070Term: Follicular B-cell non-Hodgkin´s lymphoma Class: 10029104

CTIS2024-516386-36-00AstraZeneca AB12

招募中

1 期

EUCTR2021-000870-27-FRAstraZeneca AB272