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

NCT ID: NCT01168882

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Hematological Malignancies

Keywords

RGB-286638; Hematological Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

RGB-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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agennix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RGB638-1-08-02

Identifier Type: -

Identifier Source: org_study_id