Study Stopped
Terminated early due to lack of clinical response.
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
1 other identifier
interventional
12
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2007
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedOctober 7, 2016
September 1, 2016
2.6 years
June 2, 2009
October 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the maximum tolerated dose
During the first 28 day treatment cycle
Secondary Outcomes (3)
To determine the safety and tolerability in the study population
End of the study treatment
To evaluate the pharmacokinetics of study drug
End of the study treatment
To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma
End of the study treatment
Study Arms (1)
One
EXPERIMENTALNoscapine HCl
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior chemotherapy with antimicrotubule agents
- Metastasis involving the brain or spinal cord
- Clinically significant lung or heart disease
- Abnormal electrocardiogram
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCLA
Los Angeles, California, 90024, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Columbia Presbyterian Hospital
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 3, 2009
Study Start
December 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
October 7, 2016
Record last verified: 2016-09