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

Conditions

Advanced Cancer Whose Tumours Contain Molecular Alterations

Brief summary

Module 1 - Cohort A: - Investigator assessed ORR, as defined by RECIST version 1.1., Module 1 - Cohort B: -Composite response rate (investigator assessed radiological response as defined by RECIST 1.1 for soft tissue and visceral lesions and by PCWG3 for bone lesions, PSA decline, and/or CTC conversion).

Detailed description

For Core: - AEs/SAEs - Vital signs, ECG, clinical chemistry, haematology, urinalysis and coagulation parameters., Module 1 - AEs/SAEs - Vital signs, haematology and clinical chemistry parameters., Module 1 - Cohort A: -Investigator assessment, as defined by RECIST version 1.1: - DoR - Percentage change in tumour size - PFS, Module 1 - Cohort B: -ORR by RECIST 1.1 for soft tissue and visceral lesions and by PCWG3 criteria for bone lesions. -Proportion of participants with confirmed CTC count conversion from unfavourable to favourable. -Proportion of participants with confirmed PSA decline > 50%. -Best percentage change in tumour size. -Duration of radiological responses -Radiological PFS using RECIST 1.1 for soft tissues and visceral lesions and PCWG3 for bone lesions.

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Interventions

DRUGAZD6738

DRUGCeralasertib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Module 1 - Cohort A: - Investigator assessed ORR, as defined by RECIST version 1.1., Module 1 - Cohort B: -Composite response rate (investigator assessed radiological response as defined by RECIST 1.1 for soft tissue and visceral lesions and by PCWG3 for bone lesions, PSA decline, and/or CTC conversion).	—

Secondary

Measure	Time frame
For Core: - AEs/SAEs - Vital signs, ECG, clinical chemistry, haematology, urinalysis and coagulation parameters., Module 1 - AEs/SAEs - Vital signs, haematology and clinical chemistry parameters., Module 1 - Cohort A: -Investigator assessment, as defined by RECIST version 1.1: - DoR - Percentage change in tumour size - PFS, Module 1 - Cohort B: -ORR by RECIST 1.1 for soft tissue and visceral lesions and by PCWG3 criteria for bone lesions. -Proportion of participants with confirmed CTC count conversion from unfavourable to favourable. -Proportion of participants with confirmed PSA decline > 50%. -Best percentage change in tumour size. -Duration of radiological responses -Radiological PFS using RECIST 1.1 for soft tissues and visceral lesions and PCWG3 for bone lesions.	—

Measure

Time frame

For Core: - AEs/SAEs - Vital signs, ECG, clinical chemistry, haematology, urinalysis and coagulation parameters., Module 1 - AEs/SAEs - Vital signs, haematology and clinical chemistry parameters., Module 1 - Cohort A: -Investigator assessment, as defined by RECIST version 1.1: - DoR - Percentage change in tumour size - PFS, Module 1 - Cohort B: -ORR by RECIST 1.1 for soft tissue and visceral lesions and by PCWG3 criteria for bone lesions. -Proportion of participants with confirmed CTC count conversion from unfavourable to favourable. -Proportion of participants with confirmed PSA decline > 50%. -Best percentage change in tumour size. -Duration of radiological responses -Radiological PFS using RECIST 1.1 for soft tissues and visceral lesions and PCWG3 for bone lesions.

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Countries

France

Outcome results

None listed