Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies

• Status: Withdrawn
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix

Criteria

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.