Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT01858168
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed Ewing's sarcoma
* Ewing's sarcoma must have progressed following at least one standard prior chemotherapy regimen
* Life expectancy of at least 16 weeks
* Willing to comply with the protocol for the duration of the study including pre- and post-treatment biopsies, undergoing treatment, scheduled visits and examinations including follow up
* Presence of measurable disease
* Prior approval from insurance company to obtain oral temozolomide for the duration of the study
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study
* Previous enrollment in the present study
* Participation in another clinical study with an investigational product during the 21 days prior to first dose of olaparib and temozolomide
* Receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment
* Concurrent use of the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, protease inhibitors
* Persistent clinically significant toxicities caused by previous cancer therapy
* Previously documented diagnosis of myelodysplastic syndrome (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia
* Symptomatic uncontrolled brain metastases
* Major surgery within 14 days of starting study treatment
* Considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
* Unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of study medication
* Pregnant or breastfeeding
* Known to be serologically positive for HIV and receiving antiviral therapy
* Subjects with known active hepatitis B or C
* Known hypersensitivity to olaparib or any of the excipients of the product
* Uncontrolled seizures
* Need to continue treatment with any prohibited medications or have not completed the appropriate washout period for a prohibited medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01858168
Study Brief:
Protocol Section:
NCT01858168