CompletedPhase 2

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

United States54 participantsStarted 2020-12-01

Plain-language 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

Who can participate

Age range18 Years – 130 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

Cohort A (aST): Objective Response Rate (ORR).

Timeframe: 2 years 4 months

Cohort B (mCRPC): Composite Response Rate.

Timeframe: Up to 2 years 4 months

Trial details

NCT IDNCT04564027

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-18

Results submitted2024-04-22

View on ClinicalTrials.gov More Advanced Solid Tumours trials