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Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

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ClinicalTrials.gov Identifier: NCT01583543
Recruitment Status : Completed
First Posted : April 24, 2012
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE April 18, 2012
First Posted Date  ICMJE April 24, 2012
Results First Submitted Date  ICMJE March 9, 2016
Results First Posted Date  ICMJE May 19, 2017
Last Update Posted Date May 19, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
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 Measures  ICMJE
 (submitted: April 23, 2012)
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
Change History Complete list of historical versions of study NCT01583543 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • 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 Measures  ICMJE
 (submitted: April 23, 2012)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ewing's Sarcoma
Intervention  ICMJE Drug: Olaparib
400mg PO BID Continuous
Other Name: AZD 2281
Study Arms  ICMJE Experimental: Olaparib
400mg PO BID Continuous
Intervention: Drug: Olaparib
Publications * Choy E, Butrynski JE, Harmon DC, Morgan JA, George S, Wagner AJ, D'Adamo D, Cote GM, Flamand Y, Benes CH, Haber DA, Baselga JM, Demetri GD. Phase II study of olaparib in patients with refractory Ewing sarcoma following failure of standard chemotherapy. BMC Cancer. 2014 Nov 5;14:813. doi: 10.1186/1471-2407-14-813.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2012)
24
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583543
Other Study ID Numbers  ICMJE 11-470
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwin Choy, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edwin Choy, MD PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP