| Inclusion Criteria: | 1) Patients with the following histologically confirmed relapsed hematological malignancies for whom no curative treatment or standard therapy that conveys clinical benefit is available: AML; ALL; CML currently in blast crisis (defined as >/=30% blasts in bone marrow); High-risk MDS such as RAEB-1, RAEB-2, RAEB-T, and CMML
2) Elderly patients(>/= 65 years of age) with AML who are not eligible for standard frontline chemotherapy or who refuse treatment with intensive therapy are eligible.
3) The interval from prior treatment to time of study drug administration should be at least 5 half-lives for cytotoxic and noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient may remain on hydroxyurea until 24 hours prior to the first dose of study drug.
4) Persistent clinically significant toxicities from prior chemotherapy must be </=Grade 1.
5) >/=18 years of age.
6) Eastern Clinical Oncology Group Performance Status (ECOG PS) of 0, 1, or 2.
7) Laboratory values within the following ranges: Creatinine (Cr) </=2 X the upper limit of normal (ULN); ALT and/or AST </=2.5 X the ULN; Total bilirubin </=1.5 X the ULN, unless considered due to Gilbert's syndrome
8) Negative serum or urine pregnancy test at the time of first dose for women of childbearing potential (WOCBP). For men and WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Hormonal forms of birth control (oral, implantable, or injectable) may only be used if combined with another highly effective form of birth control such as a spermicide combined with a barrier method.
9) Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
10) Ability to take oral medication.
11) Inclusion Criteria for Multiple Myeloma
12) Patients with relapsed multiple myeloma. Patients must have received at least one line of therapy, must have progressed after at least one prior therapy, and be patients for whom no standard therapy is available or who decline such options. Prior autologous and/or allogeneic transplant is permitted.
13) Patients must have measurable disease (within 14 days prior to enrollment) defined as at least one of the following: Serum monoclonal protein (M protein) >/=500 mg/dL; Urine monoclonal protein >/=200 mg per 24 hours; Involved free light chain level >/=10 mg/dL (>/=100 mg/L) and an abnormal free light chain ratio in serum (<0.26 or >1.65); Measurable soft tissue (not bone) plasmacytoma (should be measured within 28 days of first dose of study drug)
14) Persistent clinically significant toxicities from prior chemotherapy must be </=Grade 1.
15) >/=18 years of age.
16) ECOG PS of 0, 1, or 2.
17) Laboratory values within the following ranges: Absolute neutrophil count of >/=1000/mm3; Platelet count of >/=50,000/mm3; Creatinine </=2 X the ULN; ALT and/or AST </=2.5 X the ULN; Total bilirubin <1.5 X the ULN, unless considered due to Gilbert's syndrome
18) Negative serum or urine pregnancy test at the time of first dose for WOCBP. For men and WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Hormonal forms of birth control (oral, implantable, or injectable) may only be used if combined with another highly effective form of birth control such as a spermicide combined with a barrier method.
19) Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
20) Ability to take oral medication. |