Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
For Parts A & B: • Incidence and severity of AEs/SAEs • Incidence of DLTs (Dose Escalation) • Clinically significant changes in vital signs, laboratory parameters, and ECG results • Discontinuation of AZD0022 due to toxicity For Part C: • ORR evaluated according to RECIST v1.1
Detailed description
For Parts A&B: • Radiological response evaluated according to RECIST v1.1 (ORR, CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size). • OS, Continuation of Parts A&B as some translations total more than 500 characters. The proportion of participants demonstrating a complete molecular response upon treatment • Determine plasma, urine, and whole blood concentrations and where appropriate determine PK parameters including, but not limited to Cmax, tmax, AUClast, and t1/2λz after oral administration of AZD0022 and amount excreted in urine., For Part C: • Incidence of AEs/SAEs • Clinically significant changes in vital signs, laboratory parameters, and ECG results • AZD0022 discontinuation due to toxicity • Radiological response evaluated according to RECIST v1.1 (CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size), Continuation of Part C as some translation total more than 500 characters • OS • The proportion of participants demonstrating a complete molecular response upon treatment • TDT • TFST
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Parts A & B: • Incidence and severity of AEs/SAEs • Incidence of DLTs (Dose Escalation) • Clinically significant changes in vital signs, laboratory parameters, and ECG results • Discontinuation of AZD0022 due to toxicity For Part C: • ORR evaluated according to RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| For Parts A&B: • Radiological response evaluated according to RECIST v1.1 (ORR, CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size). • OS, Continuation of Parts A&B as some translations total more than 500 characters. The proportion of participants demonstrating a complete molecular response upon treatment • Determine plasma, urine, and whole blood concentrations and where appropriate determine PK parameters including, but not limited to Cmax, tmax, AUClast, and t1/2λz after oral administration of AZD0022 and amount excreted in urine., For Part C: • Incidence of AEs/SAEs • Clinically significant changes in vital signs, laboratory parameters, and ECG results • AZD0022 discontinuation due to toxicity • Radiological response evaluated according to RECIST v1.1 (CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size), Continuation of Part C as some translation total more than 500 characters • OS • The proportion of participants demonstrating a complete molecular response | — |
Countries
Belgium, Italy, Netherlands, Poland, Spain