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

Refractory Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912899
• Other study ID #: COU-NOS-001
• Status: Terminated
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: October 6, 2016
• Start date: December 2007
• Est. completion date: July 2010

Study information

• Verified date: September 2016
• Source: Cougar Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma

Intervention

Drug:
• Noscapine HCl
Escalating doses given twice per day

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	Columbia Presbyterian Hospital	New York City	New York
United States	St. Vincent's Comprehensive Cancer Center	New York City	New York
United States	Weill Medical College of Cornell University	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cougar Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose		During the first 28 day treatment cycle	No
Secondary	To determine the safety and tolerability in the study population		End of the study treatment	No
Secondary	To evaluate the pharmacokinetics of study drug		End of the study treatment	No
Secondary	To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma		End of the study treatment	No

External Links

•   MEDLINE PLUS
•   MULTIPLE MYELOMA
•   NATIONAL CANCER INSTITUTE