Refractory Multiple Myeloma
Conditions
Keywords
Refractory Multiple Myeloma, CB3304, Noscapine HCl, Multiple Myeloma
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
Interventions
DRUGNoscapine HCl
Escalating doses given twice per day
Sponsors
Cougar Biotechnology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose | During the first 28 day treatment cycle |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed