NCT01168882WithdrawnPhase 1
Phase 1 Open-label, Dose-escalation Clinical Study of the Safety and Tolerability of RGB-286638, a Novel, Multi-targeted Kinase Inhibitor, Administered to Patients With Selected, Relapsed or Refractory Hematological Malignancies
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Agennix
- Primary Endpoint
- Maximum Tolerated Dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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-
- •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.
Outcomes
Primary Outcomes
Maximum Tolerated Dose
Time Frame: 28 Days of Cycle 1
Secondary Outcomes
- Safety and Tolerability of escalating doses of RGB-286638(30 days after the last study drug is given to a subject)
- 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))
Investigators
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