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

This study has been withdrawn prior to enrollment.
(Sponsor decision to not initiate clinical trial at this time)
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT01168882
First received: July 20, 2010
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Hematological Malignancies
Drug: RGB-286638
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Agennix:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 28 Days of Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and Tolerability of escalating doses of RGB-286638 [ Time Frame: 30 days after the last study drug is given to a subject ] [ Designated as safety issue: Yes ]
    Frequency and Severity of Adverse Events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 (2003)

  • Objective Tumor Response [ Time Frame: At the Time of Final Analysis ] [ Designated as safety issue: No ]
  • Pharmacokinetic Properties [ Time Frame: At the end of Cycle 1 (28 days) ] [ Designated as safety issue: No ]
  • Pharmacodynamic properties [ Time Frame: At the end of Cycle 1 (28 days) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT01168882     History of Changes
Other Study ID Numbers: RGB638-1-08-02
Study First Received: July 20, 2010
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
RGB-286638
Hematological Malignancies

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014