Clinical trial · Interventional

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

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

NCT01168882CI-TRIAL-00007706withdrawnPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Sponsor decision to not initiate clinical trial at this time

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hematological Malignancies	Hematopoietic and Lymphoid Cell Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
RGB-286638	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Maximum Tolerated Dose
timeFrame
28 Days of Cycle 1

Secondary outcomes (4)

measure
Safety and Tolerability of escalating doses of RGB-286638
timeFrame
30 days after the last study drug is given to a subject
description
Frequency and Severity of Adverse Events based on NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 (2003)
measure
Objective Tumor Response
timeFrame
At the Time of Final Analysis
measure
Pharmacokinetic Properties
timeFrame
At the end of Cycle 1 (28 days)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.