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Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583543
First Posted: April 24, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Edwin Choy, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Objective Response Rate of Olaparib [ Time Frame: 2 years ]

    Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1.

    Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.



Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Two years ]
    Number of patients with progression free survival after two years from starting the trial.

  • Overall Survival [ Time Frame: Two years ]
    Number of patients survived for 2 years after enrolling onto this study.

  • Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event [ Time Frame: 2 years ]
    Adverse events were graded according to CTCAE v.4 (Common Terminology Criteria for Adverse Events). Events are graded on a scale of 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal. Only events that are clinically significant and which the treating investigator considers to be related to administration of olaparib are counted for this outcome measure.


Enrollment: 12
Study Start Date: May 2012
Study Completion Date: November 2014
Primary Completion Date: January 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 (ie Number of Participants With Adverse Events). 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Edwin Choy, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01583543     History of Changes
Other Study ID Numbers: 11-470
First Submitted: April 18, 2012
First Posted: April 24, 2012
Results First Submitted: March 9, 2016
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edwin Choy, MD, Massachusetts General Hospital:
Recurrent
Metastatic

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents


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