Status:
COMPLETED
Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
Lead Sponsor:
Callisto Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.
Detailed Description
This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be e...
Eligibility Criteria
Inclusion
- documented history of multiple myeloma,
- failed at least two prior regimens for multiple myeloma,
- 18 years of age or older,
- ECOG(Zubrod)PS of 0 to 2,
- screening evaluation for determining eligibility prior to enrollment,
- signed informed consent form,
Exclusion
- concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
- renal insufficiency (serum creatinine levels of \> 2mg/dL),
- mucosal bleeding,
- any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.
- clinically relevant active infection or co-morbid medical conditions.
- prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
- patients with non-secretory myeloma.
- as atiprimod is a potent inhibitor or CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00086216
Start Date
May 1 2004
End Date
November 1 2007
Last Update
December 21 2007
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030