Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

Completed · Phase 2

Conditions studied: Ewing's Sarcoma

In brief

This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult participants with recurrent/metastatic Ewing's Sarcoma following failure of prior chemotherapy.

Key facts

Study ID

NCT01583543

Run by

Massachusetts General Hospital

People needed

12

Starts

2012-05-01

Expected to finish

2014-11-01

Last updated by the study team

2017-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed Ewing's sarcoma
• Normal organ and bone marrow function
• Life expectancy of at least 16 weeks
• Not pregnant or breastfeeding
• Willing and able to comply with the protocol for the duration of the study
• Presence of measurable disease

You may not qualify if…

• Involvement in the planning and/or conduct of ths 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 study drug
• Previous exposure to any PARP inhibitor
• Receiving systemic chemotherapy or radiotherapy within 2 weeks of beginning study treatment
• Receiving prohibited classes of inhibitors of CYP3A4
• Persistent clinically significant toxicities caused by previous cancer therapy
• Known myelodysplastic syndrome 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 disorder or active, uncontrolled infection
• Unable to swallow orally administered medication or with gastrointestinal disorders likely to interfere with absorption of the study medication
• Known to be serologically positive for HIV and receiving antiretroviral therapy
• Known active Hepatitis B or C
• Known hypersensitivity to olaparib or any of the excipients of the product
• Uncontrolled seizures

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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