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Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Ewing's Sarcoma

Thank you

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 InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617