NCT02787642

A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

A Phase Ib Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma.

Detailed description

This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing four dose levels of Olaparib given with concomitant radiotherapy, followed by an expansion cohort.

Conditions

• Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression.
RADIATION	Concomitant Radiotherapy	Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8.

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-10-01
• Completion: 2022-05-01
• First posted: 2016-06-01
• Last updated: 2026-02-25
• Results posted: 2026-02-25

Locations

4 sites across 1 country: France