Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < % per year when used consistently and correctly
Recovery from the toxic effects of prior therapy, with a minimum time of: \r\n* >= days elapsed from the administration of any investigational agent\r\n* >= days elapsed from the administration of any prior cytotoxic agents, except\r\n* >= days from vincristine, >= days from procarbazine, and >= days from nitrosureas\r\n >= days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid) \r\nInvestigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < % per year when used consistently and correctly.
Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < % when used consistently and correctly
WOCBP and male subjects who are sexually active with WOCBP must agree to use highly effective methods of contraception (including a physical barrier) during the study and for days following the last dose of investigational product
Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < % when used consistently and correctly
Age, sex, and reproductive status:\r\n* Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within hours prior to the start of study drug\r\n* Women must not be breastfeeding.\r\n* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus half-lives of study drug(s) plus days (duration of ovulatory cycle) for up to months post-treatment completion\r\n* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus half-lives of study drug(s) plus days (duration of sperm turnover) for up to months post treatment completion\r\n* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however, they must still undergo pregnancy testing as described in this section\r\n* Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < % when used consistently and correctly\r\n* At a minimum subjects must agree to the use of one method of highly effective contraception as listed below. In addition, male subjects are expected to use a condom
DASATINIB\r\n* Women of childbearing 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 prior to the start of study drug\r\n* Women must not be breastfeeding\r\n* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug, plus days (duration of ovulatory cycle) for a total of days post-treatment completion\r\n* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus days (duration of sperm turnover) for a total of days post-treatment completion\r\n* Azoospermic males and WOCBP, who are not heterosexually active, are exempt from contraceptive requirements; however, WOCBP must still undergo pregnancy testing\r\n* Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective contraception; highly effective methods of contraception have a failure rate of < % when used consistently and correctly\r\n* At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective
Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however WOCBP must still undergo pregnancy testing as described; investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < % per year when used consistently and correctly; at a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below: HIGHLY EFFECTIVE METHODS OF CONTRACEPTION:\r\n* Male condoms with spermicide\r\n* Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subjects WOCBP partner\r\n* Nonhormonal IUDs, such as ParaGard\r\n* Tubal ligation\r\n* Vasectomy\r\n* Complete abstinence\r\n** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, profession of abstinence for entry into a clinical trial, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Dasatinib\r\n* Normal QTc interval on screening ECG evaluation, defined as < msec for men and < msec for women; discontinuation of any medications known to contribute significantly to the risk of QT prolongation at least hours prior to start of study drug; Levaquin and Zofran are an exception; of note, certain agents that prolong the corrected QT interval may be allowed but only after discussion with the chemotherapy pharmacist; should the investigator believe that therapy with a potentially QT prolonging medication is vital to an individual subjects care, then additional ECGs should be done at the investigators discretion to ensure the subjects safety\r\n* Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal; subjects with low K or Mg levels, total serum Ca and/or ionized Ca must be replete for protocol entry\r\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within hours prior to the start of study drug\r\n* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus days (duration of sperm turnover) for a total of days post-treatment completion\r\n* Azoospermic males and WOCBP, who are not heterosexually active, are exempt from contraceptive requirements; however, WOCBP must still under pregnancy testing as described in this section\r\n* Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective contraception; highly effective methods of contraception have a failure rate of < % when used consistently and correctly\r\n* At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed
Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however they must still undergo pregnancy testing\r\n* Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < % when used consistently and correctly
Note: investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < % when used consistently and correctly
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception\r\n** Note: women of child bearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus days after finishing the last dose\r\n** Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus days after finishing the last dose\r\n** Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however they must still undergo pregnancy testing as described in this section; note: investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy; investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; at a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:\r\n*** Male condoms with spermicide\r\n*** Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subjects WOCBP partner \r\n*** Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception\r\n*** IUDs, such as ParaGard\r\n*** Tubal ligation\r\n*** Vasectomy\r\n*** Complete abstinence\r\n**** Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence