Clinical Trial: Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Massachusetts General Hospital

Current Primary Outcome: 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.



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

Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Progression-Free Survival [ Time Frame: Two years ]
  • Overall Survival [ Time Frame: Two years ]
  • Number of Participants with Adverse Events [ Time Frame: Two years ]
    Participants will be followed during the study for all adverse events as catalogued and graded by CTCAE version #4.


Information By: Massachusetts General Hospital

Dates:
Date Received: April 18, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017