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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ewing's Sarcoma
Intervention Drug: Olaparib
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olaparib
Hide Arm/Group Description Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Olaparib
Hide Arm/Group Description Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
30.5  (15.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
1.Primary Outcome
Title Objective Response Rate of Olaparib
Hide Description

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.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib
Hide Arm/Group Description:
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Progression-Free Survival
Hide Description Number of patients with progression free survival after two years from starting the trial.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib
Hide Arm/Group Description:
This group of patients with metastatic Ewing sarcoma received single agent olaparib.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Number of patients survived for 2 years after enrolling onto this study.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib
Hide Arm/Group Description:
This group of patients with metastatic Ewing sarcoma received single agent olaparib therapy.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
4.Secondary Outcome
Title Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib
Hide Arm/Group Description:

400mg PO BID Continuous

Olaparib: 400mg PO BID Continuous

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
4
  33.3%
Time Frame From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olaparib
Hide Arm/Group Description 400 mg PO BID Continuous Olaparib
All-Cause Mortality
Olaparib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olaparib
Affected / at Risk (%)
Total   2/12 (16.67%) 
General disorders   
Death * 1 [1]  2/12 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
hemoptysis * 1  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
due to progressive disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olaparib
Affected / at Risk (%)
Total   11/12 (91.67%) 
Blood and lymphatic system disorders   
Anemia * 1  2/12 (16.67%) 
Leukopenia * 1  1/12 (8.33%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/12 (8.33%) 
Constipation * 1  1/12 (8.33%) 
Diarrhea * 1  2/12 (16.67%) 
Dry mouth * 1  2/12 (16.67%) 
Dyspepsia * 1  1/12 (8.33%) 
Dysphagia * 1  1/12 (8.33%) 
Nausea * 1  5/12 (41.67%) 
Stomach pain * 1  1/12 (8.33%) 
Vomiting * 1  4/12 (33.33%) 
Sensitive teeth * 1  1/12 (8.33%) 
General disorders   
Edema - limbs * 1  2/12 (16.67%) 
Fatigue * 1  3/12 (25.00%) 
Fever * 1  2/12 (16.67%) 
Non-cardiac chest pain * 1  2/12 (16.67%) 
Pain * 1  4/12 (33.33%) 
Immune system disorders   
Allergies * 1  1/12 (8.33%) 
Infections and infestations   
Pneumonia * 1  1/12 (8.33%) 
Upper respiratory infection * 1  1/12 (8.33%) 
Urinary tract infection * 1  2/12 (16.67%) 
Infection, other * 1  2/12 (16.67%) 
Injury, poisoning and procedural complications   
Food poisoning * 1  1/12 (8.33%) 
Investigations   
Lymphopenia * 1  1/12 (8.33%) 
Thrombocytopenia * 1  2/12 (16.67%) 
Metabolism and nutrition disorders   
Hypoglycemia * 1  1/12 (8.33%) 
Anorexia * 1  1/12 (8.33%) 
Polydipsia * 1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/12 (16.67%) 
Pain - other * 1  3/12 (25.00%) 
Nervous system disorders   
Dizziness * 1  1/12 (8.33%) 
Dysgeusia * 1  1/12 (8.33%) 
headache * 1  1/12 (8.33%) 
Psychiatric disorders   
Anxiety * 1  2/12 (16.67%) 
Insomnia * 1  2/12 (16.67%) 
Renal and urinary disorders   
Urinary hesitancy * 1  1/12 (8.33%) 
Reproductive system and breast disorders   
Perinea/ Genital numbness * 1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/12 (25.00%) 
Dyspnea * 1  1/12 (8.33%) 
Hypoxia * 1  1/12 (8.33%) 
Postnasal drip * 1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme * 1  1/12 (8.33%) 
Rash maculo-papular * 1  2/12 (16.67%) 
Cellulitis * 1  1/12 (8.33%) 
Vascular disorders   
Flushing * 1  1/12 (8.33%) 
Hot flashes * 1  1/12 (8.33%) 
Lymphedema * 1  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Edwin Choy
Organization: Massachusetts General Hospital
Phone: 617-724-4000
EMail: echoy@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Edwin Choy, MD, 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