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

  • STATUS
    Recruiting
  • End date
    Jun 8, 2023
  • participants needed
    52
  • sponsor
    AstraZeneca
Updated on 12 September 2021

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

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 will be enrolled into this cohort (ensuring at least 60% of participants with ataxia telangiectasia mutated (ATM) Immunohistochemistry [IHC] 5%).

Cohort B (Metastatic castration-resistant prostate cancer [mCRPC]): A total of ~27 molecularly eligible and centrally confirmed participants will be enrolled into Cohort B (ensuring at least 60% of participants with ATM IHC 5%). 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.

Details
Condition Advanced Solid Tumours
Treatment Ceralasertib
Clinical Study IdentifierNCT04564027
SponsorAstraZeneca
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour
Tumour must contain a deleterious or suspected deleterious ATM mutation in tumour or blood. Definitions of qualifying ATM mutations may include deleterious/suspected deleterious, pathogenic/likely pathogenic, disease- or cancer-associated variants, or equivalent wording. Variants of unknown significance, benign or likely benign alterations are not qualifying
Participant must have normal organ and bone marrow function measured within 28 days prior to the first dose of study intervention
Participants who have no curative treatment options and are deemed appropriate for an investigational study in the opinion of the investigator
Availability of archival or fresh tumour specimens for central testing of ATM protein loss using immunohistochemistry and for confirmation of ATM mutation using next generation sequencing
Previously received and progressed on at least one novel hormonal agent (eg, abiraterone acetate, apalutamide, and/or enzalutamide) for the treatment of prostate cancer
Participants with histologically confirmed metastatic castrate resistant prostate cancer
Documented prostate cancer progression at study entry while on androgen deprivation or after bilateral orchiectomy as assessed by the investigator
Serum testosterone levels 50 ng/dL ( 1.75 nmol/L) within () 28 days before enrolment

Exclusion Criteria

Any of the following cardiac diseases currently or within the last 6 months
Unstable angina pectoris
Congestive heart failure > Class 2 as defined by the New York Heart Association
Acute myocardial infarction
Significant ventricular or supraventricular arrhythmias
Mean resting corrected QT interval (QTc) > 470 msec obtained from three electrocardiograms (ECGs) in 24 hours using the Fredericia formula
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age
For Cohort B (mCRPC]), surgery or local prostatic intervention (excluding a prostatic biopsy) within 28 days of Cycle 1 Day 1
Participants with known active infections ((i.e., hepatitis B or C, tuberculosis, or COVID-19)
Participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
Participants with symptomatic uncontrolled brain metastases
Previous therapy with an telangiectasia and rad3 related protein inhibitor
Exposure to a small molecule investigational product within 14 days or 5 half-lives
Concomitant use of known strong CYP 3A inhibitors and inducers
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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