An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Callisto Pharmaceuticals.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Callisto Pharmaceuticals
Information provided by:
Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00214838
First received: September 14, 2005
Last updated: December 1, 2006
Last verified: December 2006
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Purpose
The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Atiprimod |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer |
Resource links provided by NLM:
Further study details as provided by Callisto Pharmaceuticals:
Primary Outcome Measures:
- The primary objectives of this study are to identify the maximum tolerated dose
- MTD) and to evaluate the safety of atiprimod when given in doses starting at
- 60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
- patients with advanced cancer.
Secondary Outcome Measures:
- The secondary objectives of this study are to measure the pharmacokinetics of
- atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
- advanced cancer, and 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.
| Estimated Enrollment: | 61 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2007 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214838
Locations
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Callisto Pharmaceuticals
Investigators
| Study Director: | Donald Picker, PhD | Callisto Pharmaceuticals Inc |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00214838 History of Changes |
| Other Study ID Numbers: | CP-102 |
| Study First Received: | September 14, 2005 |
| Last Updated: | December 1, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Callisto Pharmaceuticals:
|
cancer, atiprimod |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013