Actively Recruiting
A Phase I/Ib Trial of Idetrexed and Olaparib at Different Doses in Patients With High Grade Serous Ovarian Cancer
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-08-13
33
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating two drugs, Idetrexed and Olaparib, in patients with high grade serous ovarian cancer. Idetrexed targets a protein called the alpha-folate receptor on cancer cells, aiming to stop cancer growth by interfering with DNA creation. Olaparib is a PARP inhibitor that prevents cells from repairing DNA damage, leading to cell death. The study is a Phase I/Ib trial focused on assessing different doses of these drugs combined to target ovarian cancer cells with high folate receptor levels. Participants may receive one of four dose levels combining Idetrexed and Olaparib. Idetrexed is given intravenously on days 1 and 15 of each 28-day cycle at doses of 9 or 12 mg/m2. Olaparib is taken orally twice daily on days 1-7 and 15-21 at doses ranging from 150 mg to 300 mg, depending on the dose level. The study includes a dose escalation phase to find the maximum tolerated dose and a dose expansion phase for further evaluation in patients whose tumors show medium to high alpha-folate receptor expression. During the study, participants will have regular assessments including safety and toxicity evaluations up to cycle 6, and ongoing monitoring for anti-tumor activity until disease progression or a new therapy begins. Researchers will use imaging and tumor markers to measure response. The main goal is to recommend a dose for future studies while ensuring participant safety. The trial is sponsored by the Institute of Cancer Research, United Kingdom, and participation may last until progression or withdrawal, with follow-up for up to 60 months to evaluate long-term outcomes.
CONDITIONS
Brief Title
Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically proven high grade serous ovarian cancer refractory to conventional treatment or no conventional therapy exists or is declined
- Measurable or evaluable disease based on RECIST v1.1 or tumour markers
- Life expectancy of at least 12 weeks
- WHO performance status of 0-1
- Haematological and biochemical indices within protocol-defined ranges
- Normal 12-lead ECG with QTcF interval <470 ms
- Pulmonary function with FVC >70% and DLCOc >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 on tumour by Ventana FOLR1-2.1 IHC assay
You will not qualify if you...
- Radiotherapy, endocrine therapy, immunotherapy, or chemotherapy within 4 weeks (6 weeks for nitrosoureas, Mitomycin-C) before treatment
- Ongoing toxic effects from previous treatments (except alopecia or certain Grade 1 toxicities)
- New brain metastases; stable treated brain metastases allowed with negative MRI within 2 weeks
- Pulmonary metastases
- History of thoracic radiation or pre-existing lung disease
- Significant clinical ascites or pleural effusions
- Female patients of child-bearing potential who are pregnant, lactating, or not using two forms of contraception or abstinence
- Major thoracic or abdominal surgery not yet recovered from
- Sub-acute bowel obstruction
- Organ transplant recipients
- High medical risk due to non-malignant systemic disease or active uncontrolled infection
- Positive for hepatitis B, hepatitis C, or HIV
- History of significant cardiac conditions including QT prolongation, ventricular tachycardia, heart block, recent myocardial infarction, congestive heart failure, or unstable angina
- Participation in another interventional clinical trial during this study
- Inability to tolerate Olaparib
- Any condition making the patient unsuitable in investigator's opinion
- Confirmed current COVID-19 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive idetrexed intravenously on days 1 and 15 of each 28-day cycle and take olaparib orally twice per day on days 1-7 and 15-21 of each cycle at assigned dose levels.
Visits on dosing days and periodic safety assessments during treatment
Duration - Up to 60 months or until disease progression
Participants are monitored for anti-tumor activity and safety until disease progression or start of new therapy.
Periodic visits for assessments during follow-up
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.
A
Anna Zachariou, Ph.D.
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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