Back to resultsSafety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies
Primary Purpose
Hematological Malignancies
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RGB-286638
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies focused on measuring RGB-286638, Hematological Malignancies
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Secondary Outcome Measures
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)
Objective Tumor Response
Pharmacokinetic Properties
Pharmacodynamic properties
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01168882
Brief Title
Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision to not initiate clinical trial at this time
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agennix
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
Keywords
RGB-286638, Hematological Malignancies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RGB-286638
Intervention Description
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 Measure Information:
Title
Maximum Tolerated Dose
Time Frame
28 Days of Cycle 1
Secondary Outcome Measure Information:
Title
Safety and Tolerability of escalating doses of RGB-286638
Description
Frequency and Severity of Adverse Events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 (2003)
Time Frame
30 days after the last study drug is given to a subject
Title
Objective Tumor Response
Time Frame
At the Time of Final Analysis
Title
Pharmacokinetic Properties
Time Frame
At the end of Cycle 1 (28 days)
Title
Pharmacodynamic properties
Time Frame
At the end of Cycle 1 (28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies
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