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RECRUITING
NCT06976892
PHASE1

Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer

Sponsor: Institute of Cancer Research, United Kingdom

View on ClinicalTrials.gov

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

Interventions

DRUG

Dose Level 2 (starting dose)

Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 300 mg P.O. (days1-7, 15-21)

DRUG

Dose Level 1

Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)

DRUG

Dose Level -1

Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 150 mg P.O. (days1-7, 15-21)

DRUG

Dose Level 3

Idetrexed: 12 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)

DRUG

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