Back to resultsA Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Refractory Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Noscapine HCl
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma focused on measuring Refractory Multiple Myeloma, CB3304, Noscapine HCl, Multiple Myeloma
Eligibility 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.
Sites / Locations
- UCLA
- St. Vincent's Comprehensive Cancer Center
- Weill Medical College of Cornell University
- Columbia Presbyterian Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One
Arm Description
Noscapine HCl
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose
Secondary Outcome Measures
To determine the safety and tolerability in the study population
To evaluate the pharmacokinetics of study drug
To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma
Full Information
NCT ID
NCT00912899
First Posted
June 2, 2009
Last Updated
October 6, 2016
Sponsor
Cougar Biotechnology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00912899
Brief Title
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to lack of clinical response.
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cougar Biotechnology, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Multiple Myeloma
Keywords
Refractory Multiple Myeloma, CB3304, Noscapine HCl, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One
Arm Type
Experimental
Arm Description
Noscapine HCl
Intervention Type
Drug
Intervention Name(s)
Noscapine HCl
Other Intervention Name(s)
Noscapine HCl (CB3304)
Intervention Description
Escalating doses given twice per day
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose
Time Frame
During the first 28 day treatment cycle
Secondary Outcome Measure Information:
Title
To determine the safety and tolerability in the study population
Time Frame
End of the study treatment
Title
To evaluate the pharmacokinetics of study drug
Time Frame
End of the study treatment
Title
To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma
Time Frame
End of the study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York City
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Presbyterian Hospital
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.cancer.gov/
Description
NATIONAL CANCER INSTITUTE
URL
http://www.nlm.nih.gov/medlineplus/medlineplus.html
Description
MEDLINE PLUS
URL
http://www.nlm.nih.gov/medlineplus/multiplemyeloma.html
Description
MULTIPLE MYELOMA
Learn more about this trial
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma
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