NCT04564027

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumours

Interventions

Type	Name	Description
DRUG	Ceralasertib	Tablets will be administered orally

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2020-09-25
• Last updated: 2025-08-29
• Results posted: 2024-06-25

Locations

18 sites across 3 countries: United States, France, Spain

Regulatory

• FDA-regulated drug study