Clinical trial NCT01168882: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hematological Malignancies
Keywords: RGB-286638
Hematological Malignancies
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 28 Days of Cycle 1
Secondary outcomes:
measure: Safety and Tolerability of escalating doses of RGB-286638
timeFrame: 30 days after the last study drug is given to a subject
measure: Objective Tumor Response
timeFrame: At the Time of Final Analysis
measure: Pharmacokinetic Properties
timeFrame: At the end of Cycle 1 (28 days)
measure: Pharmacodynamic properties
timeFrame: At the end of Cycle 1 (28 days)
Other outcomes:
Locations:
Study officials:
References: