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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03742895




Registration number
NCT03742895
Ethics application status
Date submitted
14/11/2018
Date registered
15/11/2018

Titles & IDs
Public title
Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
Scientific title
A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer
Secondary ID [1] 0 0
MK-7339-002
Secondary ID [2] 0 0
7339-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olaparib

Experimental: Olaparib - Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).


Treatment: Drugs: Olaparib
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 53 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to 53 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 53 months
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
Up to 53 months
Secondary outcome [4] 0 0
Number of Participants Experiencing an Adverse Event (AE)
Timepoint [4] 0 0
Up to 53 months
Secondary outcome [5] 0 0
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
Timepoint [5] 0 0
Up to 52 months
Secondary outcome [6] 0 0
Objective Response Rate (ORR) in Participants with HRRm or HRD Positive Cancer
Timepoint [6] 0 0
Up to 53 months
Secondary outcome [7] 0 0
Time to Earliest Progression by Cancer Antigen-125 (CA-125)
Timepoint [7] 0 0
Up to 53 months
Secondary outcome [8] 0 0
Prostate-specific Antigen (PSA) Response Rate in Participants with Prostate Cancer
Timepoint [8] 0 0
Up to 53 months
Secondary outcome [9] 0 0
Progression-Free Survival After Next-Line Treatment in Participants with sBRCAm Breast Cancer
Timepoint [9] 0 0
Up to 53 months

Eligibility
Key inclusion criteria
* For all participants:
* Has measurable disease per RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by BICR.
* Is able to provide a newly obtained core or excisional biopsy of a tumor lesion or either an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block or slides.
* Has a life expectancy of at least 3 months.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
* Male participants must agree to use contraception during the treatment period and for at least 95 days (3 months and 5 days) after the last dose of study treatment and refrain from donating sperm during this period.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

1. Is not a woman of childbearing potential (WOCBP).
2. Is a WOCBP and using a contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days after the last dose of study intervention, AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Abstains from breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention.
* Has adequate organ function.
* For participants who have non-breast or -ovarian cancers that are breast cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are BRCA1/2 non-mutated and homologous recombination repair nonmutated:
* Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except ovarian cancer whose tumor has a germline or somatic BRCA mutation and breast cancer whose tumor has a germline BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.
* Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
* For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor, have no evidence of disease progression during the platinum chemotherapy or =4 weeks of completing the platinum-containing regimen.
* For participants who have somatic BRCAm breast cancer:
* Has histologically- or cytologically-confirmed breast cancer with evidence of metastatic disease.
* Has a known or suspected deleterious mutation in breast cancer susceptibility gene (BRCA) 1 or BRCA2 and does not harbor a germline BRCA1 or BRCA2 mutation - testing can be done centrally or locally. Blood and tissue samples must be provided by all participants.
* Has received treatment with an anthracycline unless contraindicated and a taxane in either the neoadjuvant/adjuvant or metastatic setting.
* Participants with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a known additional malignancy that is progressing or has required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
* Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate if radiologically stable, clinically stable, and without requirement for steroid treatment for at least 14 days prior to the first dose of study treatment.
* Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has known active hepatitis infection (i.e., Hepatitis B or C).
* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
* Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.
* Has a known hypersensitivity to the components or excipients in olaparib.
* Has received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT).
* Has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study treatment.
* Has received any anti-neoplastic systemic chemotherapy or biological therapy, targeted therapy, or an anticancer hormonal therapy within 3 weeks prior to the first dose of study intervention.
* Has a primary cancer of unknown origin.
* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre ( Site 2200) - Darlinghurst
Recruitment hospital [2] 0 0
MNCCI Port Macquarie Base Hospital ( Site 2201) - Port Macquarie
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd ( Site 2202) - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Nebraska
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United States of America
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New Jersey
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New York
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Oklahoma
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Pennsylvania
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South Dakota
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Utah
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Canada
State/province [19] 0 0
Ontario
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Canada
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Quebec
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Cesar
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Colombia
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Cordoba
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Colombia
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Distrito Capital De Bogota
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Colombia
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Valle Del Cauca
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Denmark
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Hovedstaden
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Denmark
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Syddanmark
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France
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Ain
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France
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Alpes-Maritimes
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France
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Alsace
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France
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Bourgogne
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France
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Gironde
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France
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Val-de-Marne
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Guatemala
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Quetzaltenango
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Guatemala
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Guatemala
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Ireland
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Carlow
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Ireland
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Cork
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Ireland
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Dublin
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Campania
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Italy
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Lombardia
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Italy
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Toscana
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Japan
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Aichi
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Japan
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Chiba
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Kyoto
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Nuevo Leon
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Queretaro
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Chihuahua
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Mexico City
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Mexico
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Oaxaca
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Peru
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La Libertad
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Peru
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Muni Metro De Lima
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Peru
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Lima
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Romania
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Bihor
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Brasov
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Romania
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Bucuresti
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Russian Federation
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Arkhangel Skaya Oblast
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Russian Federation
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Chelyabinskaya Oblast
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Ryazanskaya Oblast
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Russian Federation
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Samarskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tatarstan, Respublika
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Spain
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Madrid
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Spain
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Barcelona
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Switzerland
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Aargau
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Switzerland
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Geneve
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Switzerland
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Ticino
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Turkey
State/province [84] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Worcestershire
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Manchester
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Newcastle Upon Tyne
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03742895