Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Atiprimod	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma
Study Start Date :	May 2004
Actual Study Completion Date :	November 2007

Arms and Interventions

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Intervention Details:

Drug: Atiprimod
Oral, once a day, 14 days on 14 days off

Outcome Measures

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Primary Outcome Measures :

1. The primary objective of this study is to identify the maximum tolerated dose [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. The secondary objective of this study is to measure the pharmacokinetics of [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Callisto Pharmaceuticals

Investigators

Study Director:	Gary Jacob, PhD	Callisto Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gary Jacob, Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00086216 History of Changes
Obsolete Identifiers:	NCT00301977, NCT00491972
Other Study ID Numbers:	CP-101; efficacy; pharmacokinetics; research markers
First Posted:	June 30, 2004
Last Update Posted:	December 21, 2007
Last Verified:	December 2007

Keywords provided by Callisto Pharmaceuticals:

Multiple myeloma

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases	Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases