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Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01583543
First received: April 18, 2012
Last updated: March 26, 2014
Last verified: March 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
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: March 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Recurrent
Metastatic

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Osteosarcoma

ClinicalTrials.gov processed this record on November 25, 2014