Patients with prior malignancies, except treated non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative surgery without chemotherapy/radiation therapy > years previously will be allowed. Cancer treated with curative surgery < years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Other prior malignancy active within the previous years except for local or organ-confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study. Localized prostate cancer that has been treated surgically with curative intent and presumed cured Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > years before screening. Other prior malignancy active within the previous years except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety Prior malignancy (other than non-invasive malignancy including in situ cervical cancer, Bowen's disease or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for years before randomization Primary disease site must be able to be treated with curative intent Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment; patients with >= % of the bone marrow radiated for other diseases are not eligible ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of other malignancy which could affect compliance with the protocol or interpretation of results; history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed; subjects with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for >= years prior to cycle , day ; subjects with localized prostate cancer that has been treated with curative intent will be allowed Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > years previously will be allowed. Cancer treated with curative intent < years, which is in remission, will be reviewed on a case-by-case basis by the Protocol Officer or one of the Protocol Chairs. Participant has prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ. Cancer treated with curative intent ? years previously will be allowed. Cancer treated with curative intent < years previously will not be allowed. Randomization Exclusion Criteria Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > years previously will be allowed. Cancer treated with curative intent ? years previously will not be allowed unless approved by the Protocol Chairs and/or Protocol Officer. Malignancy treated with curative intent and with no known active disease present for ? years before enrollment Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > years before screening Second malignancy requiring concurrent treatment or those with non-hematological malignancies (except non-melanoma skin cancers); cancer treated with curative intent < years previously will not be allowed unless approved by the Protocol Chair; cancer treated with curative intent > years previously is allowed Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission Malignancy treated with curative intent and with no known active disease > years prior to the start of CMP- dosing on WD and of low potential risk for recurrence. Previous malignant disease (other than the target malignancy to be investigated in this trial) within years prior to study treatment initiation. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ, previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Principal investigator. Second malignancy that is currently clinically significant or required active intervention during the period of months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent. History of another malignancy within years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Subjects with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low risk localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any time (if complete resection was performed) are allowed. Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent > years prior to enrollment is allowed. Patients with prior invasive malignancies are allowed, provided they have been treated with definitive intent and have no evidence of active disease requiring treatment in the past years Malignancy treated with curative intent and with no known active disease present for ? years before enrollment and felt to be at low risk for recurrence by the treating physician. Prior diagnosis of non-hematologic malignancy within years of planned protocol therapy EXCEPT:\r\n* Diagnosis of breast ductal carcinoma in situ treated with curative intent\r\n* Diagnosis of prostate adenocarcinoma with Gleasons score =< treated with curative intent\r\n* Non-melanomatous skin cancer Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent > years previously will be allowed; cancer treated with curative intent =< years previously will not be allowed unless approved by the PI History of a malignancy (other than head and neck cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for years A history of other malignancy with the exception of those treated with curative intent with no evidence of disease for years A history of other malignancy, unless treated with curative intent, and no evidence of disease for at least years. History of other malignancy within the past years except treated with curative intent and no known active disease present and has not received chemotherapy for >= year before enrollment/randomization and low risk for recurrence Previous other malignancies unless they have undergone curative intent therapy for that malignancy and () have had no evidence of that disease for years, and/or () be deemed at low risk for recurrence (less than or equal to % at years) Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease Second malignancies (excluding non-melanoma skin cancer) unless treated with curative intent and disease-free for years Malignancy treated with curative intent and with no evidence of active disease present for more than years prior to screening and felt to be at low risk for recurrence by treating physician Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study Prior cytotoxic chemotherapy for another condition treated with curative intent is allowed provided at least months has elapsed between last treatment and enrollment on protocol Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is years Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment Malignancy treated with curative intent and with no known active disease present for ? years before enrollment and felt to be at low risk for recurrence by the treating physician Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last years. Subjects with history of cervical carcinoma in situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor. Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past years Active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized nonmelanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment History of a malignancy (other than melanoma) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for years Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > years before screening Malignancy treated with curative intent and with no known active disease present for ? years before the first dose of study drug and with low risk of recurrence by treating physician. Malignancy treated with curative intent and with no known active disease present for ? years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. Prior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent < years previously will not be allowed unless approved by the protocol chair; cancer treated with curative intent > years previously will be allowed Patients with prior malignancies except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent less than years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent more than years previously will be allowed Treated with intent to cure Not treated with intent to cure History of malignancy other than the underlying disease unless treated with a curative intent and/or no evidence of disease for at least years (y) OR expected to be cured with SCT Patients to be treated with RT for curative intent Other prior malignancy active within the previous years except for local or organ confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study Patients with prior malignancies are excluded unless treated with curative intent and known to be free of disease for at least years Any non-invasive malignancy not treated with curative intent or with knownactive disease within years before randomization Patients with prior malignancies, except resected non-melanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? years previously will be allowed. Cancer treated with curative intent < years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent > years will be allowed; cancer treatment with curative intent =< years will not be allowed Patients with prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent > years previously will be allowed; cancer treated with curative intent < years previously will not be allowed unless approved by the protocol officer or one of the protocol chairs Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? years previously will be allowed. Cancer treated with curative intent < years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. History of malignancy that is in complete remission after treatment with curative intent is allowed. Subject has prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? years previously will be allowed. Cancer treated with curative intent < years previously will not be allowed. Patients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanoma Known other previous/current malignancy requiring treatment within ? years except for liited disease treated with curative intent History of other malignancy within the past years with the following exception: . malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for > years before enrollment and felt to be at low risk for recurrence by the treating physician.