CompletedPhase 1

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

France41 participantsStarted 2016-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histology: patients with soft-tissue sarcoma histologically confirmed by central review (Pr Coindre team), except if the diagnosis was already confirmed by the RRePS Network,
✓. Upper/Lower limb or trunk wall soft-tissue sarcoma,
✓. Age ≥ 18 years,
✓. Locally advanced or locally recurrent primitive tumor, outside any previously irradiated field. Patients presenting operable locally Advanced or lacally recurrent tumor can be included. Patients with metastases can be included.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2,
✓. Life expectancy ≥ 6 months,
✓. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements,
✓. Adequate hematological, renal, metabolic and hepatic function:

Exclusion criteria

✕. Any previous treatment with a PARP inhibitor, including Olaparib,
✕. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication,
✕. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy,
✕. Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids,
✕. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent,
✕. Patients with uncontrolled seizures,
✕. Men or women of childbearing potential who are not using an effective method of contraception as previously describes; women who are pregnant or breast feeding,
✕. No prior or concurrent malignant disease diagnosed or treated in the last 2 years, except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,

What they're measuring

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Timeframe: Until to six weeks after end of radiotherapy

Maximum Tolerated Dose (MTD) of Olaparib in Association With Radiotherapy

Timeframe: Up to 6 weeks after end of radiotherapy for each dosing cohort

Trial details

NCT IDNCT02787642

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10

Results submitted2025-06-20

View on ClinicalTrials.gov More Soft-tissue Sarcoma trials