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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Gary Jacob, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Callisto Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CP-101

NCT ID:

NCT00086216

Start Date:

May 2004

Completion Date:

November 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096