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Merck MK7339-002: 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

Description

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).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to evaluate the objective response rate (ORR) as assessed by blinded independent central review (BICR), following olaparib administration.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except breast or ovarian cancers whose tumor has a germline or somatic 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.)
  • Have either centrally-confirmed known or suspected deleterious mutations in at least one of the genes involved in HRR or centrally-confirmed HRD
  • Have no evidence of disease progression during platinum chemotherapy (for participants receiving prior platinum [cisplatin, carboplatin or oxaliplatin either as monotherapy or in combination] for advanced [metastatic and/or unresectable] solid tumor)
  • Have measurable disease per RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by BICR
  • Are 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
  • Have a life expectancy of at least three months
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within three days of treatment initiation
  • If male, agree to use contraception during the treatment period and for at least 90 days (three months) after the last dose of study treatment and refrain from donating sperm during this period (required)
  • If female, are not pregnant or breastfeeding, are not of childbearing potential (WOCBP) or, if WOCBP, agree to use contraception during the treatment period and for at least 30 days (one month) after the last dose of study treatment (required)
  • Have adequate organ function

Excluding patients who:

  • Have a known additional malignancy that is progressing or has required active treatment in the last five 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.)
  • Have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
  • Have 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.)
  • Have 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
  • Have a known history of human immunodeficiency virus (HIV) infection
  • Have known active hepatitis infection (i.e., hepatitis B or C)
  • Are unable to swallow orally administered medication or have a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption)
  • Have received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor
  • Have a known hypersensitivity to the components or excipients in olaparib
  • Have received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT)
  • Have 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.)
Learn more about your cancer
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Asha Karippot