Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy
18 Years
N/A
Both
Ewing's Sarcoma
Trial Information
Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy
Primary Objectives Evaluate the objective response rate of olaparib in adult patients with
recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy.
Secondary Objectives To evaluate the progression-free survival, overall survival, and safety
of olaparib in this patient population. As an exploratory objective, the investigators will
evaluate (in subjects who agree to an optional biopsy) differences in pre- and
post-treatment tumor DNA alterations and differences in levels of protein and RNA expression
related to PARP inhibition.
Study Design Potential subjects who discuss and sign the informed consent form will undergo
screening studies. Eligible patients will administer olaparib and obtain restaging imaging
studies after 6 and 12 weeks on study, and then every 8 weeks thereafter. Participants will
remain on study drug until disease progression, onset of unacceptable toxicities, or subject
withdraws consent.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate of Olaparib
Outcome Description:
Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Edwin Choy, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
11-470
NCT ID:
NCT01583543
Start Date:
May 2012
Completion Date:
April 2015
Related Keywords:
- Ewing's Sarcoma
- Recurrent
- Metastatic
- Sarcoma, Ewing's
- Neuroectodermal Tumors, Primitive, Peripheral
- Sarcoma
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
