Spots Global Cancer Trial Database for A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer

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Trial Identification

Brief Title: A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer

Official Title: 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)

Study ID: NCT04564027

Conditions

Advanced Solid Tumours

Interventions

Ceralasertib

Study Description

Brief Summary: The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations

Detailed Description: Current module of the study will consist of 2 cohorts as follows: Cohort A (Advanced Solid Tumours \[AST\]): A total of \~25 molecularly eligible and centrally confirmed participants dosed at ceralasertib 160 mg twice daily will be enrolled into this cohort. Cohort B (Metastatic castration-resistant prostate cancer \[mCRPC\]): A total of \~27 molecularly eligible and centrally confirmed participants dosed at ceralasertib 160 mg twice daily will be enrolled into Cohort B. Unfavourable circulating tumour cells (CTC) count requirement may be introduced for all participants to ensure an adequate (approximately ≥ 50%) number of participants with CTC count ≥ 5/7.5 mL blood. The screening will have 2 parts, Part 1 and Part 2, which apply for both Cohort A and Cohort B.