NCT01583543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 19, 2017

Completed
Last Updated

May 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

April 18, 2012

Results QC Date

March 9, 2016

Last Update Submit

April 11, 2017

Conditions

Ewing's Sarcoma

Keywords

RecurrentMetastatic

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate of Olaparib

    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.

    2 years

Secondary Outcomes (3)

  • Progression-Free Survival

    Two years

  • Overall Survival

    Two years

  • Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event

    2 years

Study Arms (1)

Olaparib

EXPERIMENTAL

400mg PO BID Continuous

Drug: Olaparib

Interventions

OlaparibDRUG

400mg PO BID Continuous

Also known as: AZD 2281
Olaparib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 25374341RESULT

MeSH Terms

Conditions

Sarcoma, EwingRecurrenceNeoplasm Metastasis

Interventions

olaparib

Condition Hierarchy (Ancestors)

OsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Results Point of Contact

Title
Dr. Edwin Choy
Organization
Massachusetts General Hospital
echoy@mgh.harvard.edu
617-724-4000

Study Officials

  • Edwin Choy, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 24, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2014

Study Completion

November 1, 2014

Last Updated

May 19, 2017

Results First Posted

May 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)