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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)
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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
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Secondary ID [1]
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MK-7339-002
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Secondary ID [2]
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7339-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Neoplasms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who achieve a confirmed complete response (\[CR\]; disappearance of all target lesions) or partial response (\[PR\]: =30% decrease in the sum of diameters of target lesions) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1, modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ (modified RECIST 1.1). For participants with prostate cancer, ORR will be based on Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by BICR.
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Timepoint [1]
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Up to 53 months
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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DOR is defined as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. DOR will be assessed by BICR according to either modified RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer.
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Timepoint [1]
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Up to 53 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from the date of the first dose to the date of death due to any cause.
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Timepoint [2]
0
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Up to 53 months
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Secondary outcome [3]
0
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Progression Free Survival (PFS)
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Assessment method [3]
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PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression as assessed either by BICR according to modified RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer; or 2) death due to any cause, whichever occurs first.
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Timepoint [3]
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Up to 53 months
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Secondary outcome [4]
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Number of Participants Experiencing an Adverse Event (AE)
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Assessment method [4]
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An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE will be assessed.
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Timepoint [4]
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Up to 53 months
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Secondary outcome [5]
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Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
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Assessment method [5]
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The number of participants discontinuing study treatment due to an AE will be assessed.
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Timepoint [5]
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Up to 52 months
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Secondary outcome [6]
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Objective Response Rate (ORR) in Participants with HRRm or HRD Positive Cancer
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Assessment method [6]
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For participants with homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD) positive cancer, the ORR will be assessed. ORR is defined as the percentage of participants who achieve a confirmed complete response (\[CR\]; disappearance of all target lesions) or partial response (\[PR\]: =30% decrease in the sum of diameters of target lesions) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1, modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ (modified RECIST 1.1). For participants with prostate cancer, ORR will be based on Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by BICR.
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Timepoint [6]
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Up to 53 months
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Secondary outcome [7]
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Time to Earliest Progression by Cancer Antigen-125 (CA-125)
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Assessment method [7]
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For participants with BRCA1/2 non-mutated ovarian cancer only, the time to earliest progression by CA-125 will be assessed. Progression by CA-125 is defined as an increase in CA-125 level =2x upper limit normal (ULN) on 2 occasions, 1 week apart. For participants with elevated CA-125 (=ULN) at baseline, progression by CA-125 is defined as an increase in CA-125 level =2x the nadir value on 2 occasions, 1 week apart.
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Timepoint [7]
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Up to 53 months
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Secondary outcome [8]
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Prostate-specific Antigen (PSA) Response Rate in Participants with Prostate Cancer
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Assessment method [8]
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For participants with prostate cancer, the PSA response rate will be presented. PSA response rate is defined as the percentage of participants in the analysis population with PSA reduction of =50% from baseline measured twice at least 3 weeks apart.
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Timepoint [8]
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Up to 53 months
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Secondary outcome [9]
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Progression-Free Survival After Next-Line Treatment in Participants with sBRCAm Breast Cancer
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Assessment method [9]
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For participants with somatic BRCA mutated (sBRCAm) breast cancer, the PFS after next-line treatment will be presented. PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression on the next-line of treatment, as assessed by BICR according to modified RECIST 1.1; or 2) death due to any cause, whichever occurs first.
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Timepoint [9]
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Up to 53 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
390
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Kinghorn Cancer Centre ( Site 2200) - Darlinghurst
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MNCCI Port Macquarie Base Hospital ( Site 2201) - Port Macquarie
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Linear Clinical Research Ltd ( Site 2202) - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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2444 - Port Macquarie
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United Kingdom
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State/province [91]
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Manchester
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Country [92]
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United Kingdom
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State/province [92]
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Newcastle Upon Tyne
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Country [93]
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United Kingdom
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State/province [93]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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AstraZeneca
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).
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Trial website
https://clinicaltrials.gov/study/NCT03742895
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Email
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Contact person for public queries
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Toll Free Number
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Phone
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1-888-577-8839
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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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