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

October 6, 2016 updated by: Cougar Biotechnology, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA
    • New York
      • New York City, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
      • New York City, New York, United States, 10021
        • Weill Medical College of Cornell University
      • New York City, New York, United States, 10032
        • Columbia Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One
Noscapine HCl
Drug: Noscapine HCl
Escalating doses given twice per day
Other Names:
  • Noscapine HCl (CB3304)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the maximum tolerated dose
Time Frame: During the first 28 day treatment cycle
During the first 28 day treatment cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety and tolerability in the study population
Time Frame: End of the study treatment
End of the study treatment
To evaluate the pharmacokinetics of study drug
Time Frame: End of the study treatment
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
End of the study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cougar Biotechnology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COU-NOS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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