[c09aa8]: / clusters / 9knumclustersv2 / clust_2005.txt

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Female subjects of childbearing potential (defined as having a menstrual cycle within the past months and not having had a surgical procedure to accomplish sterilization) who are not using highly effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).
barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or
If a woman of childbearing potential, documentation of negative pregnancy within days prior to registration; a negative pregnancy test must also be confirmed within days of the first dose of ficlatuzumab; sexually active women of childbearing potential must agree to use adequate contraceptive measures, while on study and for days after the last dose of study drug; all fertile female subjects (and their partners) must agree to use a highly effective method of contraception; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)
Although extremely rare in this population that fertility would still be an option, a female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment; sexually active pre-menopausal female subjects of child-bearing potential must agree to use adequate, highly effective contraceptive measures, while on study and for days after the last dose of last study drug; effective birth control includes: intrauterine device (IUD) plus one barrier method; oral, implantable or injectable contraceptives plus one barrier method; barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)
If a woman of childbearing potential, documentation of negative pregnancy within days prior to first dose; sexually active patients must agree to use adequate contraceptive measures, while on study and for days after the last dose of study drug; all fertile female subjects (and their partners) must agree to use a highly effective method of contraception; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately
Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine beta-hCG [human chorionic gonadotropin]) within days of registration; sexually active pre-menopausal women of childbearing potential must agree to use adequate, highly effective contraceptive measures, starting with the first dose of study drug and for days after the last dose of last study drug; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable, or injectable contraceptives plus one barrier method; or (c) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >= year
Females of child bearing potential must use adequate contraception while on study and for at least weeks after stopping study treatment; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); females of non-childbearing potential are those who are postmenopausal greater than year (naturally; not chemotherapy induced) or who have had a bilateral tubal ligation or hysterectomy
Pregnancy: Female subjects who are pregnant, lactating or have positive serum ? HCG pregnancy test taken within days of PV- administration; Fertile subjects who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).
If a woman of childbearing potential, documentation of negative pregnancy within days prior to first dose; sexually active patients must agree to use adequate contraceptive measures, while on study and for days after the last dose of study drug; all fertile female subjects (and their partners) must agree to use a highly effective method of contraception; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately
Females of childbearing potential must have a negative pregnancy test within hours prior to initiation of protocol therapy; women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation, and months after completion of INCB; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm) (c) oral contraceptive pills and (d) intramuscular DEPO medroxyprogesterone acetate; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\r\n* NOTE: subjects are considered not of childbearing potential if they are surgically sterile, they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy or they are postmenopausal; menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential; by a practical definition, it assumes menopause after year without menses with an appropriate clinical profile at the appropriate age
If a woman of childbearing potential, documentation of negative pregnancy within days prior to first dose of ficlatuzumab; sexually active women of childbearing potential must agree to use adequate contraceptive measures, while on study and for days after the last dose of study drug; all fertile female subjects (and their partners) must agree to use a highly effective method of contraception; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)
Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than % per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence; contraception must be used during the study
Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of human chorionic gonadotropin [HCG]) within hours before the start of the investigational product; in addition, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for a minimum of month following last plerixafor dose and months following last bevacizumab dose \r\n* Effective birth control includes:\r\n** Birth control pills, depot progesterone, or an intrauterine device plus one barrier method\r\n** Or barrier methods\r\n* Effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)\r\n* Hormonal contraceptive methods are not sufficient, as information about any interaction of plerixafor with hormonal contraceptives is not known\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Female subjects of child-bearing potential and male subjects with partners of child-bearing potential must agree to use an effective means of birth control while on study therapy and for a minimum of months following last plerixafor dose and months following last bevacizumab dose\r\n* Effective birth control includes:\r\n** Birth control pills, depot progesterone, or an intrauterine device plus one barrier method\r\n** or barrier methods\r\n* Effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)\r\n* Hormonal contraceptive methods are not sufficient, as information about any interaction of plerixafor with hormonal contraceptives is not known\r\n* Men or women of child-bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy (noted above) for the entire study period and for up to weeks after the last dose of study drug are excluded from this study
Male subjects with partners of child-bearing potential, even if surgically sterilized (ie, status postvasectomy) must agree to abstain from sexual activity or to use medically approved contraceptive measures / regimens from the time of signing the informed consent form through months after the treatment period\r\n* Effective birth control includes: (a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method; or (b) barrier methods; effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); for subjects using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known
Women of childbearing potential must have negative urine pregnancy test. Sexually active women must agree to use two forms of accepted methods of contraception during the course of the study and for months after their last dose of study drug. Effective birth control includes IUD plus one barrier method; on stable doses of hormonal contraception for at least months plus one barrier method; barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides; or vasectomized partner
A female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment; sexually active pre-menopausal female subjects (and male subjects whose sexual partners are of childbearing potential) must agree to use adequate, highly effective contraceptive measures, while on study and for days after the last dose of last study drug; effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) barrier methods; effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)
Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for days after the last dose of study drug. All fertile male and female subjects (and their partners) must agree to use a highly effective method of contraception. Highly effective birth control includes (a) IUD plus one barrier method; or (b) barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P interactions, and are not considered effective for this study.)