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

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

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 Overview

• Status: Withdrawn
• Conditions: Hematological Malignancies
• Intervention / Treatment: Drug: RGB-286638

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerated Dose	28 Days of Cycle 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of escalating doses of RGB-286638	Frequency and Severity of Adverse Events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 (2003)	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)

Collaborators and Investigators

• Sponsor: Agennix

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): August 2, 2012
• Last Update Submitted That Met QC Criteria: August 1, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Hematological Malignancies; RGB-286638
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: RGB638-1-08-02