Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086216
• Other study ID #: CP-101
• Secondary ID: efficacypharmaco
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 28, 2004
• Last updated: December 20, 2007
• Start date: May 2004
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: Callisto Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00301977
• NCT00491972

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Callisto Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to identify the maximum tolerated dose		1 year	No
Secondary	The secondary objective of this study is to measure the pharmacokinetics of		1 year	Yes