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

Phase 1

Terminated

• Conditions: Refractory Multiple Myeloma
• Interventions: Drug: Noscapine HCl

• Registration Number: NCT00912899
• Lead Sponsor: Cougar Biotechnology, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One	Noscapine HCl	Noscapine HCl

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose	During the first 28 day treatment cycle

Secondary Outcome Measures

Name	Time	Method
To determine the safety and tolerability in the study population	End of the study treatment
To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma	End of the study treatment
To evaluate the pharmacokinetics of study drug	End of the study treatment

Trial Locations

Locations (4)

Columbia Presbyterian Hospital; 🇺🇸 New York City, New York, United States

St. Vincent's Comprehensive Cancer Center; 🇺🇸 New York City, New York, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Weill Medical College of Cornell University; 🇺🇸 New York City, New York, United States