Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

Ewing's Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583543
• Other study ID #: 11-470
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2012
• Last updated: March 8, 2016
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ewing's Sarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• Olaparib
400mg PO BID Continuous

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & 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. BM — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate of Olaparib	Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy	2 years	No
Secondary	Progression-Free Survival		Two years	No
Secondary	Overall Survival		Two years	No
Secondary	Number of Participants with Adverse Events	Participants will be followed during the study for all adverse events as catalogued and graded by CTCAE version #4.	Two years	Yes