Phase 2
N=12
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
Ewing's Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT01583543 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
May 2017
Primary outcome: Primary: Objective Response Rate of Olaparib — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Olaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate of Olaparib |
— | — |
| SECONDARY Progression-Free Survival |
— | — |
| SECONDARY Overall Survival |
1 | — |
| SECONDARY Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event |
4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01583543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.