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

NCT02489006 | Unknown Phase 2

• 1 other identifier: OZM-058
• Study Type: interventional
• Target: 71
• Locations: 4 countries
• Sites: 9

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Neoadjuvant Treatment; Debulking Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• Difference in levels of PAR or PARP-1 before and after study treatment

  4-8 weeks

• Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue

  2.5 years

Secondary Outcomes (7)

• Frequency of adverse events, by description and grade

  2.5 years

• Response rate to olaparib in the neoadjuvant period

  6 weeks

• Duration of progression free survival with olaparib in comparison to platinum based chemotherapy

  2.5 years

• Levels of ctDNA compared to levels of CA125

  2.5 years

• Gene expression changes in tumour tissue before and after treatment with Olaparib

  2.5 years

Study Arms (2)

Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery

EXPERIMENTAL

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; Drug: Platinum-based Chemotherapy

Olaparib Prior to Surgery and Post Surgery

EXPERIMENTAL

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

Drug: Olaparib

Interventions

Olaparib DRUG

Also known as: Lynparza

Olaparib Prior to Surgery and Post Surgery; Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery

Platinum-based Chemotherapy DRUG

Chosen by the study doctor, per standard of care.

Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (9)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM

Montreal, Quebec, H2L 2W5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Auckland City Hospital

Grafton, Auckland, New Zealand

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

olaparib; Platinum Compounds

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre/University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: July 2, 2015
• Study Start: July 19, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

ES (1); CA (5); NZ (1); GB (2)