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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00912899
Recruitment Status : Terminated (Terminated early due to lack of clinical response.)
First Posted : June 3, 2009
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Refractory Multiple Myeloma Drug: Noscapine HCl Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: One
Noscapine HCl
Drug: Noscapine HCl
Escalating doses given twice per day
Other Name: Noscapine HCl (CB3304)

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

Secondary Outcome Measures :
  1. To determine the safety and tolerability in the study population [ Time Frame: End of the study treatment ]
  2. To evaluate the pharmacokinetics of study drug [ Time Frame: End of the study treatment ]
  3. To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma [ Time Frame: End of the study treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912899

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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.
Additional Information:
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Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00912899    
Other Study ID Numbers: COU-NOS-001
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: September 2016
Keywords provided by Cougar Biotechnology, Inc.:
Refractory Multiple Myeloma
Noscapine HCl
Multiple Myeloma
Additional relevant MeSH terms:
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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