Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma - Full Text View

Sponsored by:	Callisto Pharmaceuticals
Information provided by:	Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00086216

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: Atiprimod	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: SK&F 106615

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma

Further study details as provided by Callisto Pharmaceuticals:

Primary Outcome Measures:

The primary objective of this study is to identify the maximum tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective of this study is to measure the pharmacokinetics of [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	May 2004
Study Completion Date:	November 2007

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086216

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

Responsible Party:	Callisto Pharmaceuticals ( Gary Jacob )
Study ID Numbers:	CP-101, efficacy, pharmacokinetics, research markers
Study First Received:	June 28, 2004
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00086216
Health Authority:	United States: Food and Drug Administration

Keywords provided by Callisto Pharmaceuticals:

Multiple myeloma

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009