search
Back to results

Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atiprimod
Sponsored by
Callisto Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

The primary objective of this study is to identify the maximum tolerated dose

Secondary Outcome Measures

The secondary objective of this study is to measure the pharmacokinetics of

Full Information

First Posted
June 28, 2004
Last Updated
December 20, 2007
Sponsor
Callisto Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00086216
Brief Title
Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
Official Title
An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Callisto Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atiprimod
Intervention Description
Oral, once a day, 14 days on 14 days off
Primary Outcome Measure Information:
Title
The primary objective of this study is to identify the maximum tolerated dose
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The secondary objective of this study is to measure the pharmacokinetics of
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Jacob, PhD
Organizational Affiliation
Callisto Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

We'll reach out to this number within 24 hrs