Ceralasertib for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Advanced Solid TumorsCeralasertib - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effectiveness, safety, and tolerability of drugs that may help repair DNA damage in people with advanced cancer.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: From Screening (Day -28 to Day -1) until Safety follow-up (30 days after last dose) (upto approximately 3 years)

Year 3
Cohort A and Cohort B: Best percentage change in tumour size
Cohort A: Duration of Radiological response (DoR) by RECIST version 1.1
Cohort A: Objective response rate (ORR) by response evaluation ceiteria in solid tumours (RECIST) version 1.1
Cohort A: Progression free survival (PFS) by RECIST version 1.1
Cohort B: Composite response rate by RECIST version 1.1
Cohort B: Duration of radiological response.
Cohort B: ORR by RECIST version 1.1
Cohort B: Proportion of participants with confirmed CTC count conversion from unfavourable to favourable
Cohort B: Proportion of participants with confirmed prostate specific antigen (PSA) decline ≥ 50%
Cohort B: Radiological progression free survival (rPFS) by RECIST 1.1
Year 3
Cohort A and B: Number of participants with serious and non-serious adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Cohort A
1 of 2
Cohort B
1 of 2

Experimental Treatment

61 Total Participants · 2 Treatment Groups

Primary Treatment: Ceralasertib · No Placebo Group · Phase 2

Cohort A
Drug
Experimental Group · 1 Intervention: Ceralasertib · Intervention Types: Drug
Cohort B
Drug
Experimental Group · 1 Intervention: Ceralasertib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening (day -28 to day -1) until safety follow-up (30 days after last dose) (upto approximately 3 years)

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,857,401 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically confirmed diagnosis of AST or mCRPC tumour.
You have prostate cancer and are receiving androgen deprivation therapy or bilateral orchiectomy.
Availability of tumour specimens for central testing of ATM protein loss using immunohistochemistry and for confirmation of ATM mutation using next generation sequencing.
You have histologically confirmed metastatic castrate resistant prostate cancer.