Clinical trial NCT02483104 (phase 1, status: completed)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: veliparib, carboplatin, paclitaxel
SMILES: C[C@@]1(CCCN1)C1=NC2=CC=CC(C(N)=O)=C2N1, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

        Histologically or cytologically confirmed epithelial ovarian, fallopian tube or primary
        peritoneal carcinoma the International Federation of Gynecology and Obstetrics (FIGO) Stage
        IC - IV with either optimal (< 1 cm residual disease) or suboptimal residual disease.

        Participants must be newly diagnosed, chemotherapy-naïve, and entered between 1 and 12
        weeks after initial cytoreductive surgery.

        Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

        Adequate organ and marrow function.

        Ability to swallow and retain oral medication, and no uncontrolled emesis.

        Women of childbearing potential (except vasectomized partner of female subjects) must agree
        to use adequate contraception prior to study entry, for the duration of study participation
        and up to 3 months following completion of therapy. Women of childbearing potential must
        have a negative urine or serum pregnancy test within 7 days prior to the study entry. Post
        menopausal women must be amenorrheic for at least 12 months to be considered of
        non-childbearing potential.

        Exclusion Criteria:

        A history of another invasive cancer within the past 3 years, except non-melanoma skin
        cancer or in situ malignancies that are considered cured by the investigator (e.g.,
        cervical cancer in situ, in situ carcinoma of the bladder, or breast carcinoma in situ).

        Participants who received prior radiotherapy to any portion of the abdominal cavity or
        pelvis.

        Participants who received prior chemotherapy for any abdominal or pelvic tumor.

        Any investigational agents less than 4 weeks prior to study enrollment.

        Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.

        Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo Colourant
        Tartrazine (also known as FD&C Yellow 5 or E102), Azo Colourant Orange Yellow-S (also known
        as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

        Patients with history or evidence upon physical examination of central nervous system
        disease, including primary brain tumor, any brain metastases, or history of cerebrovascular
        accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of the first date
        of treatment on this study.

        Prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

        Subject has a clinically significant uncontrolled condition(s), including but not limited
        to:

          -  Uncontrolled seizure disorder, or focal or generalized seizure within the last 12
             months;

          -  Active infection that requires parenteral antibiotics;

          -  Known active hepatitis B or hepatitis C with abnormal liver function test or organ
             dysfunction;

          -  Symptomatic congestive heart failure; unstable angina pectoris; serious ventricular
             cardiac arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or
             serious cardiac arrhythmia requiring medication (this does not include asymptomatic
             atrial fibrillation with controlled ventricular rate); or myocardial infarction within
             the last 6 months;

          -  Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic
             pressure > 100 mmHg despite optimal medical management);

          -  Bowel obstruction or gastric outlet obstruction;

          -  Psychiatric illness/social situations that would limit compliance with study
             requirements;

          -  Any medical condition which in the opinion of the Investigator places the subject at
             an unacceptably high risk for toxicities.

        Pregnant or lactating.