Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Ewing's Sarcoma	Drug: Olaparib	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: Ewing sarcoma

MedlinePlus related topics: Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Objective Response Rate of Olaparib [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy

Secondary Outcome Measures:

Progression-Free Survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
Number of Participants with Adverse Events [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Participants will be followed during the study for all adverse events as catalogued and graded by CTCAE version #4.

Estimated Enrollment:	24
Study Start Date:	May 2012
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Olaparib 400mg PO BID Continuous	Drug: Olaparib 400mg PO BID Continuous Other Name: AZD 2281

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583543

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Edwin Choy, MD PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Edwin Choy, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01583543 History of Changes
Other Study ID Numbers:	11-470
Study First Received:	April 18, 2012
Last Updated:	December 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Recurrent
Metastatic

Additional relevant MeSH terms:

Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on June 18, 2013