Eligibility Details:
Inclusion Criteria:
- Has 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.
- 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.
- 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 3 days of treatment initiation.
- Male participants must agree to use contraception during the treatment period and for
at least 90 days (3 months) after the last dose of study treatment and refrain from
donating sperm during this period.
- Female participants must not be pregnant or breastfeeding. Additionally, female
participants must either not be a woman of childbearing potential (WOCBP) or, if a
WOCBP, agree to use contraception during the treatment period and for at least 30 days
(1 month) after the last dose of study treatment.
- Has adequate organ function.
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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
