Data

A Phase II signal-seeking trial targeting recurrent high grade serous ovarian cancer (HGSC) with Cyclin E1 (CCNE1) over-expression with and without gene amplification - IGNITE

Australia New Zealand Gynaecological Oncology Group

Dataset description

Dataset contains: - Data for 80 patients with recurrent high grade serous ovarian carcinoma with Cyclin E1 (CCNE1) overexpression - Approximate time period of data collection 2020-2026 - Clinical benefit rate at 18 weeks post-intervention commencement - Toxicity - Progression free survival, overall survival - Best overall response (BOR) - Duration of response (DoR)
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Source Study

Trial acronym

IGNITE

Trial ID

ACTRN12619001185156

Purpose

Treatment

Phase

Phase 2

Funding

Other Collaborative groups,Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Scientific enquiries

Dr George Au-Yeung

Brief Summary

This study will determine if the use of adavosertib as monotherapy provides clinical benefit to patients with high grade serous ovarian cancer Who is it for? You may be eligible to join this study if you are aged 18 and above and have platinum resistant high grade serous ovarian cancer with Cyclin E1 over-expression Study details Participants in this study are enrolled into one of two cohorts based on their tissue screening results. Cohort 1 will enrol 32 participants who have Cyclin E1 over-exp ....
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Key Inclusion Criteria

1. Patient has provided written informed consent for the Main part of the study 2. Patient continues to meet all pre-screening inclusion criteria 3. Patient’s tumour has a confirmed Cyclin E over-expression defined by IHC - Tumours with Cyclin E over-expression will have CCNE1 copy number assessed by FISH to determine which cohort patients will be assigned 4. Patient has platinum resistant HGSC, defined as progressive disease by imaging < 6 months from last date of most recent platinum-based the ....
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Key Exclusion Criteria

1. Patient has had prior treatment with Wee1 kinase inhibition 2. Use of anti-cancer treatment drug less than or equal to 21 days or 5 half-lives (whichever is shorter) prior to registration; for drugs for which 5 half-lives is less than or equal to 21 days, a minimum of 10 days between termination of the prior treatment and registration into the study is required - Patients on luteinizing hormone-releasing hormone (LHRH) analogue treatment for more than 6 months are allowed entry into the study ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    96

Min. age    18 Years

Max. age    No limit

Sex    Females

Condition category    Cancer of the falllopian tube , Ovarian Cancer , Primary peritoneal cancer

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

Patients will be recruited to one of two cohorts based on the results of the pre-screening tissue testing: Cohort 1: Cyclin E1 over-expressed and amplified; or Cohort 2: Cyclin E1 over-expressed and non-amplified Patients will receive 300mg of adavosertib in the form of a daily oral tablet to be taken on Days 1-5 and then Days 8-12 of each 21-day cycle, for a maximum duration of 24 months (based on clinical response at the discretion of the investigator). Adherence to the intervention is recorde ....
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Comparison

Control group Uncontrolled

No control group

Outcomes

Outcome: To determine the clinical benefit rate (CBR, defined as absence of progression for = 18 weeks by RECIST 1.1 among patients with measurable disease and GCIG CA-125 criteria among patients without measurable disease)
Timepoint: 18 weeks post-intervention commencement

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au