Clinical Trial Details
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[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01858168 : Phase I Study of Olaprib and Temozolomide for Ewings Sarcoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
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
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