Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies
Phase 1
Withdrawn
- Conditions
- Hematological Malignancies
- Registration Number
- NCT01168882
- Lead Sponsor
- Agennix
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose 28 Days of Cycle 1
- Secondary Outcome Measures
Name Time Method 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)