Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00912899
First received: June 2, 2009
Last updated: February 15, 2011
Last verified: October 2009
History of Changes
  Purpose

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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and tolerability in the study population [ Time Frame: End of the study treatment ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics of study drug [ Time Frame: End of the study treatment ] [ Designated as safety issue: No ]
  • To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma [ Time Frame: End of the study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: November 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912899

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
United States, New York
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
St. Vincent's Comprehensive Cancer Center
New York City, New York, United States, 10011
Sponsors and Collaborators
Cougar Biotechnology, Inc.
  More Information

Additional Information:
AMERICAN SOCIETY OF CLINICAL ONCOLOGY  This link exits the ClinicalTrials.gov site
COUGAR BIOTECHNOLOGY  This link exits the ClinicalTrials.gov site
NATIONAL CANCER INSTITUTE  This link exits the ClinicalTrials.gov site
MEDLINE PLUS  This link exits the ClinicalTrials.gov site
MULTIPLE MYELOMA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Christopher Haqq, MD PhD / VP Clinical Research and Development, Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00912899     History of Changes
Other Study ID Numbers: COU-NOS-001
Study First Received: June 2, 2009
Last Updated: February 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cougar Biotechnology, Inc.:
Refractory Multiple Myeloma
CB3304
Noscapine HCl
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Noscapine
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents

ClinicalTrials.gov processed this record on May 21, 2013