A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma

Phase 1TerminatedNCT00912899

Cougar Biotechnology, Inc.12 enrolled

Overview

This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety \& tolerability of noscapine HCl in patients with advanced multiple myeloma

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Refractory Multiple Myeloma

Interventions

Noscapine HClDRUG

Escalating doses given twice per day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Advanced Multiple Myeloma. * Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®). * ECOG performance status of either 0 or 1. Exclusion Criteria: * Prior chemotherapy with antimicrotubule agents * Metastasis involving the brain or spinal cord * Clinically significant lung or heart disease * Abnormal electrocardiogram Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria. Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Locations (4)

UCLA

Los Angeles, California, United States

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Columbia Presbyterian Hospital

New York, New York, United States

Outcomes

Primary Outcomes

To determine the maximum tolerated dose

Time frame: During the first 28 day treatment cycle

Secondary Outcomes

To determine the safety and tolerability in the study population

Time frame: End of the study treatment

To evaluate the pharmacokinetics of study drug

Time frame: End of the study treatment

To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma

Time frame: End of the study treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.