Clinical trial NCT00086216: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Lead sponsor: Callisto Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary objective of this study is to identify the maximum tolerated dose
timeFrame: 1 year
Secondary outcomes:
measure: The secondary objective of this study is to measure the pharmacokinetics of
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Callisto Pharmaceuticals
name: Gary Jacob, PhD
role: STUDY_DIRECTOR
References: