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

Agennix

Status and phase

Withdrawn

Phase 1

Conditions

Hematological Malignancies

Treatments

Drug: RGB-286638

Study type

Interventional

Funder types

Industry

Identifiers

NCT01168882

RGB638-1-08-02

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.