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

This study has been terminated.
(Terminated early due to lack of clinical response.)
Information provided by (Responsible Party):
Cougar Biotechnology, Inc. Identifier:
First received: June 2, 2009
Last updated: October 6, 2016
Last verified: September 2016
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

Condition Intervention Phase
Refractory Multiple Myeloma
Drug: Noscapine HCl
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:
  • To determine the maximum tolerated dose [ Time Frame: During the first 28 day treatment cycle ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One
Noscapine HCl
Drug: Noscapine HCl
Escalating doses given twice per day
Other Name: Noscapine HCl (CB3304)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00912899

United States, California
Los Angeles, California, United States, 90024
United States, New York
St. Vincent's Comprehensive Cancer Center
New York City, New York, United States, 10011
Weill Medical College of Cornell University
New York City, New York, United States, 10021
Columbia Presbyterian Hospital
New York City, New York, United States, 10032
Sponsors and Collaborators
Cougar Biotechnology, Inc.
  More Information

Additional Information:
Responsible Party: Cougar Biotechnology, Inc. Identifier: NCT00912899     History of Changes
Other Study ID Numbers: COU-NOS-001
Study First Received: June 2, 2009
Last Updated: October 6, 2016

Keywords provided by Cougar Biotechnology, Inc.:
Refractory Multiple Myeloma
Noscapine HCl
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antitussive Agents
Respiratory System Agents processed this record on May 25, 2017