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

NCT01168882 | Withdrawn Phase 1 DMC

• 1 other identifier: RGB638-1-08-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  28 Days of Cycle 1

Secondary Outcomes (4)

• 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)

Interventions

RGB-286638 DRUG

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agennix: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

RGB 286638

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 23, 2010
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2015
• Last Updated: August 2, 2012

Record last verified: 2012-08