NCT01661868

Brief Summary

This research study is a way of gaining new knowledge about a drug called olaparib in women who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1) or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from repairing their DNA. In this research study, we are looking to see how well the drug olaparib works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well as those who have received a prior PARP inhibitor and whose cancer has re-grown after receiving that PARP inhibitor.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

Same day

First QC Date

October 24, 2011

Last Update Submit

August 18, 2012

Conditions

Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Keywords

BRCA1 mutationBRCA2 mutation

Outcome Measures

Primary Outcomes (1)

  • Response Rates

    To determine the RECIST 1.1. response rates of the oral PARP inhibitor olaparib based on prior exposure of a PARP inhibitor; patients who have received and subsequently have had disease progression with a prior PARP inhibitor versus no prior exposure to a PARP inhibitor in patients with germline BRCA mutations who have recurrent ovarian, fallopian tube or peritoneal cancer who have measurable cancer.

    1 year

Secondary Outcomes (3)

  • Toxicity

    1 year

  • Progression free survival

    1 year

  • Response Rate

    1 year

Study Arms (2)

PARP Inhibitor Naive

ACTIVE COMPARATOR

Patients with no prior PARP inhibitor treatment

Drug: Olaparib

Prior PARP Inhibitor

ACTIVE COMPARATOR

Patients previously treated with a PARP inhibitor other than olaparib

Drug: Olaparib

Interventions

OlaparibDRUG

Tablet formulation will be used.

Also known as: AZD2281
PARP Inhibitor NaivePrior PARP Inhibitor

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis
  • Measurable disease
  • Estimated life expectancy greater than 16 weeks
  • Normal organ and marrow function
  • Evidence of non-childbearing status for women of childbearing potential
  • Able to swallow oral medication

You may not qualify if:

  • Pregnant or breastfeeding
  • Prior PARP inhibitor use for another cancer such as breast cancer
  • Receiving any other study agents or any other anti-cancer treatment
  • Known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of a different malignancy unless disease-free for at least 5 years
  • Currently experiencing seizures or currently being treated with any anti-epileptic for seizures
  • Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy
  • Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Ursula A Matulonis, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2011

First Posted

August 10, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

US(1)