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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Multiple Myeloma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose

Outcome Time Frame:

During the first 28 day treatment cycle

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

COU-NOS-001

NCT ID:

NCT00912899

Start Date:

November 2007

Completion Date:

July 2010

Related Keywords:

  • Refractory Multiple Myeloma
  • Refractory Multiple Myeloma
  • CB3304
  • Noscapine HCl
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021
Columbia Presbyterian HospitalNew York, New York  10032
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
UCLALos Angeles, California  90095