Hematological Malignancies
Conditions
Keywords
RGB-286638, Hematological Malignancies
Brief 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.
Interventions
DRUGRGB-286638
The starting dose is a flat-fixed dose of 40 mg given i.v. over 60 min, weekly x3, of a 28-days cycle (q4 weeks)
Sponsors
Agennix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose | 28 Days of Cycle 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of escalating doses of RGB-286638 | 30 days after the last study drug is given to a subject | Frequency and Severity of Adverse Events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 (2003) |
| Objective Tumor Response | At the Time of Final Analysis | — |
| Pharmacokinetic Properties | At the end of Cycle 1 (28 days) | — |
| Pharmacodynamic properties | At the end of Cycle 1 (28 days) | — |
Outcome results
None listed