Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

NCT ID: NCT00086216

Last Updated: 2007-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-11-30

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 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.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Atiprimod

Oral, once a day, 14 days on 14 days off

Intervention Type: DRUG

Eligibility Criteria

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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Callisto Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Callisto Pharmaceuticals

Principal Investigators

Gary Jacob, PhD

Role: STUDY_DIRECTOR

Callisto Pharmaceuticals

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

efficacy

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pharmacokinetics

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research markers

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CP-101

Identifier Type: -

Identifier Source: org_study_id

NCT00301977

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NCT00491972

Identifier Type: -

Identifier Source: nct_alias