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A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (NEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489006
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Last Update Posted : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE April 17, 2015
First Posted Date  ICMJE July 2, 2015
Last Update Posted Date May 16, 2022
Actual Study Start Date  ICMJE July 19, 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • Difference in levels of PAR or PARP-1 before and after study treatment [ Time Frame: 4-8 weeks ]
  • Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue [ Time Frame: 2.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • Frequency of adverse events, by description and grade [ Time Frame: 2.5 years ]
  • Response rate to olaparib in the neoadjuvant period [ Time Frame: 6 weeks ]
  • Duration of progression free survival with olaparib in comparison to platinum based chemotherapy [ Time Frame: 2.5 years ]
  • Levels of ctDNA compared to levels of CA125 [ Time Frame: 2.5 years ]
  • Gene expression changes in tumour tissue before and after treatment with Olaparib [ Time Frame: 2.5 years ]
  • Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression [ Time Frame: 2.5 years ]
    2.5 years
  • Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib [ Time Frame: 2.5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Official Title  ICMJE A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients With Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian Tube Cancer
Brief Summary This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.
Detailed Description

Olaparib belongs to a class of anti-cancer agents known as poly ADP-ribose polymerase (PARP) inhibitors. Olaparib is a new type of drug for ovarian cancer. Laboratory tests show that it may help slow the growth of ovarian cancer.

Olaparib works by blocking the PARP protein. PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are thought to develop from damaged DNA. Research has shown that PARP inhibitors stop the PARP protein from working, and that sometimes that can cause cancer cells to stop growing or die.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Neoadjuvant Treatment
  • Debulking Surgical Procedures
Intervention  ICMJE
  • Drug: Olaparib
    Other Name: Lynparza
  • Drug: Platinum-based Chemotherapy
    Chosen by the study doctor, per standard of care.
Study Arms  ICMJE
  • Experimental: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery

    Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery.

    Platinum-based chemotherapy chosen by the study doctor and per standard of care after surgery.

    Olaparib, orally, at 300 mg twice per day, continuously, after chemotherapy.

    Interventions:
    • Drug: Olaparib
    • Drug: Platinum-based Chemotherapy
  • Experimental: Olaparib Prior to Surgery and Post Surgery
    Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery.
    Intervention: Drug: Olaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven recurrent high grade serous ovarian/primary peritoneal or fallopian tube cancer.
  • Patients must have disease amenable to pre-operative biopsy.
  • Patients must have disease deemed suitable for surgical debulking.
  • Patients must have a progression free interval of at least 6 months prior to registration.
  • Patients must have had at least one line of platinum based therapy.
  • Patients must have shown platinum sensitivity to their last line of platinum therapy
  • Age >=18 years
  • ECOG performance status 0-1 within 7 days of registration
  • Life expectancy of greater than 3 months
  • Patients must have normal organ and marrow function
  • Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
  • History of allergic reactions attributed to platinum precluding further use.
  • Radiation therapy within 4 weeks of registration
  • Use of any other systemic, targeted, immunotherapy, chemotherapy, or investigational agents within 4 weeks of registration
  • Previously received a PARP inhibitor
  • Other malignancy within the last 2 years with exceptions
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Concomitant use of known potent CYP3A4 inhibitors
  • Concomitant use of known potent CYP3A4 inducers
  • Other anti-cancer therapy including immunotherapy, hormonal therapy, biological therapy, other novel agents or investigational agents
  • Persistent toxicities (CTCAE v 4.03 grade >2) caused by previous cancer therapy, excluding alopecia
  • Patients with myelodysplastic syndrome/acute myeloid leukemia
  • Patients with brain metastases
  • Immunocompromised 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
  • Pregnant or breastfeeding women
  • Receipt of live attenuated vaccine within 30 days prior to enrollment
  • Patients with > Grade 2 hearing impairment as per CTCAE v 4.03
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   New Zealand,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489006
Other Study ID Numbers  ICMJE OZM-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre/University Health Network
PRS Account University Health Network, Toronto
Verification Date May 2022

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