A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: Niraparib
Intervention description: Niraparib capsule
Intervention MeSH terms: Niraparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      Niraparib in Japanese participants with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Japanese male or female participants aged 20 years or older on the day of signing
             informed consent.

          2. Participants must have a cytologically- or histologically-confirmed metastatic or
             locally advanced solid tumor and have failed or progressed after standard therapy, or
             for which standard therapy does not exist in the opinion of the investigator.

          3. Participants must have Performance Status of less than or equal to (<=) 1 on the
             Eastern Cooperative Oncology Group (ECOG) Performance Status Scale.

          4. Participants must have adequate organ function as indicated by the following
             laboratory values:

               1. Hematology

                    -  Absolute neutrophil count: greater than or equal to (>=) 1500 per microliter
                       (μL)

                    -  Platelet count: >=100,000/μL

                    -  Hemoglobin: >=9 gram per deciliter (g/dL)

               2. Kidney

                  - Serum creatinine: <=1.5*institutional upper limit of normal (ULN), OR
                  creatinine clearance of >=50 milliliter per minute (mL/min) (as calculated using
                  the Cockcroft Gault equation or measured using 24-hour urine creatinine
                  clearance) for participants with creatinine levels >=1.5*institutional ULN.

               3. Liver

                    -  Total bilirubin in serum: <=1.5*ULN (except in participants with Gilbert's
                       syndrome). Participants with Gilbert's syndrome may be enrolled if the
                       participant's direct bilirubin is <=1.5*ULN of the direct bilirubin.

                    -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT):
                       <=2.5*ULN OR <=5*ULN if participants have liver metastases.

               4. Coagulation (does not pertain to participants receiving anticoagulants)

                    -  Prothrombin time (PT): <=1.2*ULN

                    -  Activated partial thromboplastin time (aPTT): <=1.2*ULN

          5. Female participants who:

               -  Are postmenopausal for at least 1 year before the screening visit, OR

               -  Are surgically sterile, OR

               -  If they are of childbearing potential, agree to practice one highly effective
                  method of contraception and one additional effective (barrier) method at the same
                  time, from the time of signing the informed consent through 180 days after the
                  last dose of study drug, OR

               -  Agree to practice true abstinence, when this is in line with the preferred and
                  usual lifestyle of the participant. (Periodic abstinence [eg, calendar,
                  ovulation, symptothermal, postovulation methods], condoms only, withdrawal,
                  spermicides only, and lactational amenorrhea are not acceptable methods of
                  contraception. Female and male condoms should not be used together.)

             Male participants, even if surgically sterilized (ie, vasectomy), who:

               -  Agree to practice effective barrier contraception during the entire study
                  treatment period and through 120 days after the last dose of study drug. If the
                  female partner of a male participant is of child bearing potential, it should
                  also be advised to use a highly effective method of contraception, OR

               -  Agree to practice true abstinence, when this is in line with the preferred and
                  usual lifestyle of the participant. (Periodic abstinence [eg, calendar,
                  ovulation, symptothermal, postovulation methods for the female partner], condoms
                  only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable
                  methods of contraception. Female and male condoms should not be used together.)

          6. Voluntary written consent must be given before performance of any study related
             procedure not part of standard medical care, with the understanding that consent may
             be withdrawn by the participant at any time without prejudice to future medical care.

        Exclusion Criteria:

          1. Participant who have received chemotherapy, radiotherapy, hormonal or biological
             therapy within 14 days (within 28 days for anticancer monoclonal antibody, within 42
             days for nitrosoureas or mitomycin C) prior to Cycle 1 Day 1. If the participant has
             residual toxicity from prior chemotherapy treatment, such toxicity must be <=Grade 1
             (NOTE: participants with Grade 2 alopecia may qualify for this study). If bevacizumab
             had been used in the past, all bevacizumab-related toxicities must have resolved.
             Participants with prostate cancer may have been treated with luteinizing
             hormone-releasing hormone (LH-RH) analogs.

          2. Participants who received a known or putative poly (ADP-ribose) polymerase (PARP)
             inhibitor or other drugs that may inhibit the PARP, either as part of a clinical trial
             or as standard of care.

          3. Participants who initiated bisphosphonate therapy or are adjusting bisphosphonate
             dose/regimen within 30 days prior to Cycle 1 Day 1. Participants on a stable
             bisphosphonate regimen are eligible and may continue the treatment.

          4. Treatment with any investigational products within 28 days or 5 half-lives (whichever
             was longer) before Cycle 1 Day 1.

          5. Participants who have symptomatic ascites or a symptomatic pleural effusion. A
             participant who is treated and clinically stable for these conditions is eligible.

          6. Participants with a known primary central nervous system (CNS) tumor.

          7. Participants with known CNS metastases and/or carcinomatous meningitis are excluded.
             However, participants with CNS metastases who have completed a course of therapy would
             be eligible for the study provided they are clinically stable for 30 days prior to
             Cycle 1 Day 1 defined as: (1) no evidence of new or enlarging CNS metastases, (2) off
             steroids, or (3) on a stable dose and administration of steroids.

          8. Participants who have a hypersensitivity to the components of the study drugs or their
             analogs.

          9. Participants who are considered to be at high medical risk due to a serious,
             uncontrolled disease, non-malignant systemic disease or active, uncontrolled
             infection. Examples include, but are not limited to, uncontrolled ventricular
             arrhythmia, recent (within 90 days prior to Cycle 1 Day 1) myocardial infarction,
             uncontrolled major seizure disorder, unstable spinal cord compression, superior vena
             cava syndrome, uncontrolled hypertension, or any psychiatric disorder that prohibits
             obtaining informed consent.

         10. Participants who have a history or current evidence of any condition, therapy, or lab
             abnormality that might confound the results of the study, interfere with the
             participant's participation throughout the study period, or study participation is not
             in the best interest of the participant.

         11. Known gastrointestinal (GI) disease or GI surgery that could interfere with the GI
             absorption of study drug, such as difficulty swallowing capsules and total
             gastrectomy.

         12. Participants who have a psychiatric disorder that may interfere with the conduct of
             the trial.

         13. Participant is, at the time of signing informed consent, a regular user (including
             "recreational use") of any illicit drugs or had a recent history (within the past
             year) of drug or alcohol abuse.

         14. Participants who are pregnant or breast-feeding, or expecting to conceive or be a
             father of children within the planned duration of the study.

             NOTE: If a breast-feeding woman discontinue breast-feeding, she may be enrolled in the
             study.

         15. Known human immunodeficiency virus positive.

         16. Known hepatitis B surface antigen (HBsAg) positive, or known or suspected active
             hepatitis C virus (HCV) infection.

        NOTE: Participants who are positive for hepatitis B core antibody (HBcAb) or hepatitis B
        surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus
        (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must
        have an undetectable HCV viral load.