Clinical trial NCT00214838: An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
Official title: An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: cancer, atiprimod
Lead sponsor: Callisto Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 61
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.

Detailed description: The primary objectives of this study are to identify the maximum tolerated dose(MTD) and to evaluate safety of atiprimod in patients with advanced cancer.

The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.

Eligibility criteria: Inclusion Criteria:

* histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
* estimated life expectancy of at least 12 weeks.
* must have evaluable disease.
* ECOG(Zubrod) PS of 0 to 2
* sign informed consent.
* age 13 years or more at time of signing informed consent.

Exclusion Criteria:

* renal insufficiency
* concomitant radiotherapy, chemotherapy or other investigational therapies.
* peripheral neuropathy grade 3 or greater (NCI CTC version 3 grading)
* evidence of clinically significant mucosal or internal bleeding
* any condition that 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 serious co-morbid medical conditions.
* as atiprimod is a potent inhibitor of CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics will be excluded.

Primary outcomes:
measure: The primary objectives of this study are to identify the maximum tolerated dose
measure: MTD) and to evaluate the safety of atiprimod when given in doses starting at
measure: 60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
measure: patients with advanced cancer.
Secondary outcomes:
measure: The secondary objectives of this study are to measure the pharmacokinetics of
measure: atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
measure: advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
measure: capsules at the starting dose, with the intent of switching to capsules for
measure: the dose escalation if the capsules pose no safety issues.
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Callisto Pharmaceuticals Inc
name: Donald Picker, PhD
role: STUDY_DIRECTOR
References: