Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

Last updated: December 20, 2007
Sponsor: Callisto Pharmaceuticals
Overall Status: Completed

Phase

1/2

Condition

Bone Diseases

Multiple Myeloma

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT00086216
CP-101
research markers
pharmacokinetics
efficacy
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • concomitant therapy medications including corticosteroids or other chemotherapy thatis 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 atunacceptable 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 orsquamous cell skin cancer, in situ cervical cancer, or other cancer for which thepatient 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 aresubstrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will beexcluded.

Study Design

Total Participants: 30
Study Start date:
May 01, 2004
Estimated Completion Date:
November 30, 2007

Study 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 escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.

Connect with a study center

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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