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Активно (без набиране) Фаза 2 NCT03742895

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)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Advanced Solid Neoplasms

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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).
Кой може да участва
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. 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.
Места на провеждане 21
Argentina (1)
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)
Berazategui , Buenos Aires
Австралия (1)
Kinghorn Cancer Centre ( Site 2200)
Darlinghurst , New South Wales
Канада (1)
Sunnybrook Research Institute ( Site 0210)
Toronto , Ontario
Colombia (1)
Fundacion Centro de Investigacion Clinica CIC ( Site 2812)
Medellín , Antioquia
Дания (1)
Rigshospitalet ( Site 0402)
Copenhagen , Capital Region
Франция (1)
CHU Poitiers ( Site 0612)
Poitiers , Ain
Guatemala (1)
Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
Guatemala , Departamento de Quetzaltenango
Ireland (1)
Mater Misericordiae University Hospital ( Site 1654)
Dublin , Carlow
Израел (1)
Soroka Medical Center ( Site 0800)
Beersheba
Италия (1)
Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
Naples , Campania
Япония (1)
Aichi Cancer Center Hospital ( Site 2602)
Nagoya , Aichi-ken
Mexico (1)
Actualidad Basada en la Investigacion del Cancer ( Site 2903)
Guadalajara , Jalisco
Peru (1)
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)
Trujillo , La Libertad
Румъния (1)
S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)
Oradea , Bihor County
Russia (1)
Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
Arkhangelsk , Arkhangelskaya oblast
Южна Корея (1)
Seoul National University Bundang Hospital ( Site 2402)
Seongnam-si , Kyonggi-do
Испания (1)
Hospital Universitario Quiron Madrid ( Site 1352)
Pozuelo de Alarcón , Madrid
Швейцария (1)
Universitaetsspital Zuerich ( Site 1400)
Zuerich , Canton of Aargau
Турция (1)
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
Konya , Adana
Великобритания (1)
Churchill Hospital ( Site 1606)
Oxford , Worcestershire
САЩ (1)
The University of Arizona Cancer Center - North Campus ( Site 0011)
Tucson , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
12.12.2018
Крайна дата
30.06.2026
Регистрационен номер
NCT03742895
Източник
anzctr
Запитване за медицински туризъм

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