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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2016 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02489006
First received: April 17, 2015
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Ovarian Cancer Fallopian Tube Cancer Neoadjuvant Treatment Debulking Surgical Procedures Drug: Olaparib Drug: Platinum-based Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 71
Study Start Date: July 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Olaparib
Other Name: Lynparza
Drug: Platinum-based Chemotherapy
Chosen by the study doctor, per standard of care.
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.
Drug: Olaparib
Other Name: Lynparza

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02489006

Contacts
Contact: Amit Oza, M.D. 416-946-2818

Locations
Canada, Alberta
Tom Baker Cancer Centre Not yet recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Prafull Ghatage, M.D.    403-521-3721      
Principal Investigator: Prafull Ghatage, M.D.         
Canada, Ontario
Juravinski Cancer Centre Not yet recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Holger (Hal) Hirte, M.D.    (905) 387-9495      
Principal Investigator: Holger (Hal) Hirte, M.D.         
London Regional Cancer Centre Not yet recruiting
London, Ontario, Canada, N6A 4L6
Contact: Stephen Welch, M.D.    416-685-8640      
Ottawa Regional Cancer Centre Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Johanne Weberpals, M.D.    519-737-8899 ext. 76462      
Principal Investigator: Johanne Weberpals, M.D.         
Canada, Quebec
Hôpital Notre-Dame Not yet recruiting
Montréal, Quebec, Canada, H2L 4M1
Contact: Diane Provencher, M.D.    514-890-8000 ext 27244      
Principal Investigator: Diane Provencher, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre/University Health Network
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02489006     History of Changes
Other Study ID Numbers: OZM-058
Study First Received: April 17, 2015
Last Updated: June 21, 2016

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 22, 2017