Sponsor decision to not initiate clinical trial at this time

The purpose of the study is to determine the safety and tolerability of RGB-286638, a novel, multi-targeted kinase inhibitor, administered to patients with selected, relapsed or refractory hematological malignancies.

Inclusion Criteria:

• Histologically/cytologically confirmed diagnosis of:

  • Multiple myeloma (MM)
  • Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
  • Mantle Cell Lymphoma (MCL)
  • Chronic Myelogenous Leukemia (CML)

• Refractory to/relapsed after and/or intolerant of one or more standard therapies or for which no standard therapy exists.

• ECOG performance status 0-2.

• Adequate bone marrow, cardiovascular, renal and hepatic function

• Recovery from all adverse events due to prior therapies

• Contraception

Exclusion Criteria:

• Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy (involving ≥ 30% of the active bone marrow) within 14 days prior to the first dose (note nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose of RGB-286638).
• CNS involvement of the hematological malignancy.
• Active or unstable cardiac disease and/or history of myocardial infarction within 6 months and/or history of clinically significant ventricular arrhythmias.
• Concomitant therapies that are known to prolong the QT interval and are associated with a risk of Torsades de Pointes (TdP) are not permitted within 7 days before the first dose; however, amiodarone is not permitted within 90 days before the first dose.
• Patients with uncontrolled and unstable intercurrent illness.
• Concomitant therapy with inhibitors and/or inducers of CYP450 3A4 within 1 week of the first dose.
• Bleeding disorder unrelated to hematological malignant disease.
• HIV or HIV-related malignancy.
• History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 2 years.
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.