Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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

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)

Details

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.

Keywords

Advanced Solid Tumours Ataxia telangiectasia mutated Metastatic castration-resistant prostate cancer Rad3-related protein Ceralasertib

Eligibility

You can join if…

Open to people ages 18-130

  • Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour.
  • Participants must have a deleterious or suspected deleterious ATM mutation in tumour or blood (germline or ctDNA). 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.

You CAN'T join if...

  • 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 and/or 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.

Locations

  • Research Site accepting new patients
    San Francisco California 94115 United States
  • Research Site withdrawn
    Beverly Hills California 90211 United States
  • Research Site withdrawn
    La Jolla California 92093 United States
  • Research Site withdrawn
    Sacramento California 95817 United States
  • Research Site not yet accepting patients
    Los Angeles California 90089 United States
  • Research Site accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT04564027
Phase
Phase 2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 61 study participants
Last Updated