Breast Cancer Clinical Trial
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.
Key Inclusion Criteria:
Age ≥ 18 at the time of screening
Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
Life expectancy ≥ 12 weeks
Progressive cancer at the time of study entry
Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
Adequate organ and marrow function as defined by the protocol.
For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
For Part A:
- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
For Part B:
- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
Key Exclusion Criteria:
Treatment with any of the following:
Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong and moderate inhibitors or inducers.
Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.
Major surgery within 4 weeks of the first dose of study treatment.
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
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 >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
Cardiac conditions as defined by the clinical study protocol
Other cardiovascular diseases as defined by any of the following:
Symptomatic heart failure,
hypertensive heart disease with significant left ventricular hypertrophy
acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
cardiomyopathy of any etiology
presence of clinically significant valvular heart disease
history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
transient ischaemic attack, or stroke within 6 months prior to screening
patients with symptomatic hypotension at screening
Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305
Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
other module-specific criteria may apply
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There are 58 Locations for this study
San Francisco California, 94143, United States
Boston Massachusetts, 02114, United States
Foxboro Massachusetts, 02035, United States
New York New York, 10021, United States
Oklahoma City Oklahoma, 73104, United States
Houston Texas, 77030, United States
Melbourne , 3000, Australia
Kelowna British Columbia, V1Y 5, Canada
Vancouver British Columbia, V5Z 1, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Quebec , G1R 2, Canada
Changsha , 41001, China
Changsha , 41001, China
Chengdu , 61004, China
Chengdu , 61004, China
Chongqing , 40003, China
Guangzhou , 51006, China
Jining , 27202, China
Shanghai , 20003, China
Taiyuan , 03000, China
Wuhan , 43007, China
Xi'an , 71006, China
Brno , 656 5, Czechia
Budapest , 1062, Hungary
Budapest , 1083, Hungary
Budapest , 1122, Hungary
Milano , 20132, Italy
Milan , 20141, Italy
Modena , 41125, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Roma , 00168, Italy
Chuo-ku , 104-0, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Bydgoszcz , 85-79, Poland
Gdynia , 81-51, Poland
Grzepnica , 72-00, Poland
Lublin , 20-09, Poland
Toruń , 87-10, Poland
Warszawa , 02-78, Poland
Moscow , 11112, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 11799, Russian Federation
Moscow , 14344, Russian Federation
Barcelona , 08035, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Málaga , 29010, Spain
Sevilla , 41013, Spain
Cambridge , CB2 0, United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
Sutton , SM2 5, United Kingdom
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