Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Olaparib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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