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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168882
Recruitment Status : Withdrawn (Sponsor decision to not initiate clinical trial at this time)
First Posted : July 23, 2010
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: RGB-286638 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2015

Intervention Details:
  • Drug: 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)

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 28 Days of Cycle 1 ]

Secondary Outcome Measures :
  1. Safety and Tolerability of escalating doses of RGB-286638 [ Time Frame: 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)

  2. Objective Tumor Response [ Time Frame: At the Time of Final Analysis ]
  3. Pharmacokinetic Properties [ Time Frame: At the end of Cycle 1 (28 days) ]
  4. Pharmacodynamic properties [ Time Frame: At the end of Cycle 1 (28 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 0-2.
  • 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.
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Responsible Party: Agennix Identifier: NCT01168882    
Other Study ID Numbers: RGB638-1-08-02
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012
Keywords provided by Agennix:
Hematological Malignancies
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases