Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Callisto Pharmaceuticals
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.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
