Actively Recruiting
Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-08-13
33
Participants Needed
3
Research Sites
226 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
A
Algok Bio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Two drugs called Idetrexed and olaparib are being evaluated. Idetrexed is a type of drug called an "aFR-targeted thymidylate synthase inhibitor". Idetrexed has been designed to selectively target cancer cells that have a protein called folate receptor on the surface of cancer cells. Thymidylate synthase is key to cancer cells for creating new DNA when they multiply. Blocking the action of thymidylate synthase with a drug like Idetrexed may therefore stop cancers from growing by damaging DNA in cancer cells. Olaparib is a type of drug called a "PARP inhibitor". It prevents cells repairing DNA damage. This leads to cells dying. Combining Idetrexed and olaparib should increase the number of cancer cells dying, especially those cells that have a lot of folate receptors. Cancer cells with a high number of folate receptors should be targeted more than normal healthy cells.
CONDITIONS
Official Title
Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed high grade serous ovarian cancer that is refractory to conventional treatment, or no conventional therapy exists or is declined by the patient
- Measurable disease by RECIST v1.1 or evaluable disease based on tumor markers
- Life expectancy of at least 12 weeks
- World Health Organisation (WHO) performance status of 0-1
- Blood and biochemistry tests within defined ranges performed within 7 days before first dose
- Normal 12-lead ECG with QTcF interval less than 470 ms
- Pulmonary function tests showing FVC greater than 70% and DLCOc greater than 60%
- Age 18 years or older
- Signed informed consent and ability to cooperate with treatment and follow-up
- For dose expansion, medium to high alpha-folate receptor expression by Ventana FOLR1-2.1 IHC assay
You will not qualify if you...
- Radiotherapy (except palliative), endocrine, immunotherapy, or chemotherapy within 4 weeks prior to treatment (6 weeks for nitrosoureas or Mitomycin-C)
- Ongoing toxic effects from previous treatments except alopecia or certain Grade 1 toxicities approved by investigator
- Presence of new brain metastases; treated and stable brain metastases allowed if treatment was at least 4 weeks prior and negative brain MRI within 2 weeks before study drug
- Pulmonary metastases present
- History of thoracic radiation or lung disease likely to affect lungs
- Significant clinical ascites or pleural effusions
- Female patients who are pregnant, lactating, or of child-bearing potential without agreed contraception or sexual abstinence
- Major thoracic or abdominal surgery not recovered from
- Sub-acute bowel obstruction
- Organ transplant recipients
- High medical risk from uncontrolled systemic disease or active infection
- Positive for hepatitis B, hepatitis C, or HIV
- History of serious heart conditions including QT prolongation, significant arrhythmias, recent heart attacks, heart failure NYHA Class III/IV, unstable angina
- Participation in another interventional clinical trial during this study
- Inability to tolerate Olaparib
- Any other condition making the patient unsuitable in investigator's opinion
- Confirmed current COVID-19 infection
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Not Yet Recruiting
2
Royal Marsden Hospital - Drug Development Unit
Sutton, London, United Kingdom, SM2 5NG
Actively Recruiting
3
Velindre Cancer Centre
Cardiff, Wales, United Kingdom
Not Yet Recruiting
Research Team
A
Alexander Cowley, Ph.D.
CONTACT
A
Anna Zachariou, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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