NCT02340611

Brief Summary

This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful adding investigational drug cediranib to olaparib after disease progression on olaparib alone in patients with ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

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

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

January 13, 2015

Last Update Submit

June 11, 2018

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients whose cancer shrinks or disappears after treatment

    2 years

Secondary Outcomes (4)

  • Percentage of decrease in CA-125 levels after treatment

    2 years

  • Mutation status of genes compared to response to treatment

    2 years

  • Number of occurences per side effect and severity

    2 years

  • Assess patient reported outcomes during treatment

    2 years

Study Arms (1)

Cediranib and Olaparib

EXPERIMENTAL

Cediranib, 20 mg , orally, once a day, every day. Olaparib, 150 mg or 200 mg (depending on previous treatment dose), orally, once a day, every day.

Drug: OlaparibDrug: Cediranib

Interventions

OlaparibDRUG

Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor

Also known as: AZD2281, KU-0059436
Cediranib and Olaparib
CediranibDRUG

Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3)

Also known as: AZD2171, Recentin™
Cediranib and Olaparib

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Performance status 2 or less
  • Ovarian cancer, high grade serous or high grade endometrioid histology subtype
  • Radiographically documented disease progression per RECIST 1.1
  • Progression on olaparib therapy after an initial good response (more than 6 months)
  • Patients must have adequate bone marrow, renal and hepatic function per local laboratory reference range
  • Ongoing prior toxicities related to previous treatments recovered to grade 2 or less
  • LVEF\>50% by echocardiograms or MUGA
  • Urine dipstick for proteinuria \<2+
  • Willing to undergo tumour biopsy pre-treatment
  • Life expectancy of greater than 3 months
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Current bowel obstruction
  • Known brain metastases
  • Mean QTc \>470 msec (with Bazett's correction) in screening ECG or history of familial long QT syndrome.
  • Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • A New York Heart Association classification of III or IV requiring concurrent use of drugs or biologics with proarrhythmic potential.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or cediranib
  • Unable to swallow orally administered medication and/or gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Myelodysplastic syndrome/acute myeloid leukaemia
  • Immuno-compromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with known active hepatitis (i.e.,hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

olaparibcediranib

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 Disorders

Study Officials

  • Amit Oza, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

CA(1)