Advanced Cancer Whose Tumours Contain Molecular Alterations MedDRA version: 21.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: AZD6738 20 mg film-coated tablet
Product Code: AZD6738
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ceralasertib
CAS Number: 1352226-88-0
Current Sponsor code: AZD6738
Ot
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain a preliminary assessment of the efficacy of study intervention as assessed by response rate. Module 1 - Cohort A: To obtain a preliminary assessment of the efficacy of ceralasertib in participants with ATM altered AST refractory to standard treatments options, as assessed by ORR. Module 1 - Cohort B: To obtain a preliminary assessment of the efficacy of ceralasertib in participants with ATM altered metastatic castration-resistant prostate cancer previously treated with NHA and/or chemotherapy (if appropriate), as assessed by composite response rate.;Secondary Objective: - To obtain a preliminary assessment of further efficacy endpoints with study intervention. - To assess the safety and tolerability profile of study intervention. Module 1 - Cohort A: -To further assess the efficacy of ceralasertib. -To assess the safety and tolerability profile of ceralasertib. Module 1 - Cohort B: -To further assess the efficacy of ceralasertib. -To assess the safety and tolerability profile of ceralasertib.;Primary end point(s): For Module 1 Cohort A: - Investigator assessed ORR, as defined by RECIST version 1.1. Cohort B: -Composite response rate (investigator assessed radiological response by RECIST 1.1 for soft tissue and visceral lesions and PCWG3 for bone lesions, PSA decline, and/or CTC conversion).;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - AEs/SAEs - Vital signs, ECG, clinical chemistry, haematology, urinalysis and coagulation parameters. Module 1 Cohort A: -Investigator assessment, as defined byRECIST version 1.1: ? DoR ? Percentage change in tumour size ? PFS Cohort B: -ORR by RECIST 1.1 for soft tissue and visceral lesions and PCWG3 criteria for bone metastases. -Proportion of participants with confirmed CTC count conversion from unfavourable to favourable. -Proportion of participants with confirmed PSA decline = 50%. -Percentage change in tumour size. -Radiological PFS using RECIST 1.1 for soft tissues and visceral lesions and PCWG3 for bone lesions.;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
France, Spain, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed