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

June 2, 2009
February 15, 2011
November 2007
July 2010   (final data collection date for primary outcome measure)
To determine the maximum tolerated dose [ Time Frame: During the first 28 day treatment cycle ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00912899 on ClinicalTrials.gov Archive Site
  • 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 ]
To Determine the Safety and Tolerability in the Study Population [ Time Frame: During Study Treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
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

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Multiple Myeloma
Drug: Noscapine HCl
Escalating doses given twice per day
Other Name: Noscapine HCl (CB3304)
Experimental: One
Noscapine HCl
Intervention: Drug: Noscapine HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2010
July 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00912899
COU-NOS-001
No
Christopher Haqq, MD PhD / VP Clinical Research and Development, Cougar Biotechnology, Inc.
Cougar Biotechnology, Inc.
Not Provided
Not Provided
Cougar Biotechnology, Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP