Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01583543
First received: April 18, 2012
Last updated: March 26, 2014
Last verified: March 2014

April 18, 2012
March 26, 2014
May 2012
April 2014   (final data collection date for primary outcome measure)
Objective Response Rate of Olaparib [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy
Same as current
Complete list of historical versions of study NCT01583543 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Participants will be followed during the study for all adverse events as catalogued and graded by CTCAE version #4.
Same as current
Not Provided
Not Provided
 
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy

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.

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. 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ewing's Sarcoma
Drug: Olaparib
400mg PO BID Continuous
Other Name: AZD 2281
Experimental: Olaparib
400mg PO BID Continuous
Intervention: Drug: Olaparib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
April 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01583543
11-470
Yes
Edwin Choy, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Edwin Choy, MD PhD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

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