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

Hematological Malignancies Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01168882
• Other study ID #: RGB638-1-08-02
• Status: Withdrawn
• Phase: Phase 1
• First received: July 20, 2010
• Last updated: August 1, 2012
• Start date: November 2011
• Est. completion date: July 2015

Study information

• Verified date: August 2012
• Source: Agennix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematological Malignancies
• Neoplasms

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		28 Days of Cycle 1	Yes
Secondary	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	Yes
Secondary	Objective Tumor Response		At the Time of Final Analysis	No
Secondary	Pharmacokinetic Properties		At the end of Cycle 1 (28 days)	No
Secondary	Pharmacodynamic properties		At the end of Cycle 1 (28 days)	No