Clinical Research Directory
Browse clinical research sites, groups, and studies.
Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
Sponsor: Institute of Cancer Research, United Kingdom
Summary
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.
Official title: A Phase I/Ib Trial of Idetrexed (Alpha Folate Receptor Targeted Thymidylate Synthase Inhibitor) in Combination With Olaparib (a PARP Inhibitor) at Different Doses in Patients With Ovarian Cancer (IDOL)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2025-08
Completion Date
2029-12
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
Dose Level 2 (starting dose)
Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 300 mg P.O. (days1-7, 15-21)
Dose Level 1
Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)
Dose Level -1
Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 150 mg P.O. (days1-7, 15-21)
Dose Level 3
Idetrexed: 12 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)
Maximum Tolerated Dose
MTD of Olaparib in combination with idetrexed established from Dose Escalation
Locations (3)
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Royal Marsden Hospital - Drug Development Unit
Sutton, London, United Kingdom
Velindre Cancer Centre
Cardiff, Wales, United Kingdom