- Present with histological or cytological evidence of a diagnosis of cancer (solid
tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or
metastatic. The patient must be, in the judgement of the investigator, an
appropriate candidate for experimental therapy after available standard therapies
have been used.
- Have the presence of measurable or nonmeasurable disease as defined by Response
Evaluation Criteria in Solid Tumors (RECIST), Revised International Working Group
Lymphoma Response Criteria, or National Cancer Institute Working Group Guidelines for
Chronic Lymphocytic Leukemia.
- Have adequate organ function.
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group
- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 3 months following the last dose
of study drug.
- Females with child bearing potential must have had a negative serum pregnancy test
less than or equal to 7 days prior to the first dose of study drug.
- Have discontinued chemotherapy and cancer-related hormonal therapy with
commercially-available agents for at least 21 days (6 weeks for mitomycin-C or
nitrosoureas) and radiotherapy for at least 14 days prior to study enrollment and
recovered from the acute effects of therapy (less than or equal to National Cancer
Institute's Common Terminology Criteria for Adverse Events (CTCAE v 4.02; Grade 1).
Hormone refractory prostate cancer patients receiving gonadotropin releasing hormone
(GnRH) agonist therapy or breast cancer patients on anti-estrogen therapy (for
example, an aromatase inhibitor) prior to entrance on the study may have that
treatment continued while they are enrolled in Study CXBA.
- Have an estimated life expectancy of greater than or equal to 12 weeks.
- Have received treatment with an investigational drug, which has not received
regulatory approval for any indication, within 28 days of study treatment with
- Have medical conditions that, in the opinion of the investigator, would preclude
participation in this study.
- Have symptomatic central nervous system malignancy or metastasis. Patients with
treated CNS metastases are eligible provided their disease is radiographically
stable, asymptomatic, and they are not currently receiving corticosteroids and/or
anticonvulsants. Screening of asymptomatic patients without history of CNS metastases
is not required.
- Have a history of major organ transplant.
- Have current acute leukemia.
- Have active human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C
- Have QTc greater than 470 msec (female) or greater than450 msec (male), history of
congenital long QT syndrome or other conduction abnormality.
- Have had an autologous or allogenic bone marrow transplant.
- Previously treated with a CXCR4 antagonist, or have had a significant allergy to