Clinical trial · Interventional
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy
NCT01583543CI-TRIAL-00027696completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing's Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Olaparib
- description
- 400mg PO BID Continuous
- interventionNames
- Drug: Olaparib
Primary outcomes (1)
- measure
- Objective Response Rate of Olaparib
- timeFrame
- 2 years
- description
- Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcomes (3)
- measure
- Progression-Free Survival
- timeFrame
- Two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChoy E, Butrynski JE, Harmon DC, Morgan JA, George S, Wagner AJ, D'Adamo D, Cote GM, Flamand Y, Benes CH, Haber DA, Baselga JM, Demetri GD. Phase II study of olaparib in patients with refractory Ewing sarcoma following failure of standard chemotherapy. BMC Cancer. 2014 Nov 5;14:813. doi: 10.1186/1471-2407-14-813. PMID 25374341