Status:
COMPLETED
Extension Study of the Safety and Efficacy of Atiprimod Treatment in Neuroendocrine Carcinoma
Lead Sponsor:
Callisto Pharmaceuticals
Conditions:
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is an extension study to the Callisto protocol CP-106. Subjects must have completed all 12 treatment cycles of CP-106 without disease progression as per RECIST criteria,to be eligible to to...
Detailed Description
For carcinoid, despite the many cytotoxic chemotherapy trials that have been conducted, no regimen has demonstrated a response rate of more than 20% using the criterion of a 50% reduction of bidimensi...
Eligibility Criteria
Inclusion
- Subject was enrolled in Protocol No. CP-106 and successfully completed 12 treatment cycles.
- Subject must have been classified as a responder at the time of completion of Protocol No. CP-106 \[i.e., SD or better per RECIST Committee criteria or stable symptoms or better (defined as an average daily frequency of bowel movements, flushing episodes and/or wheezing episodes that is the same as or less than the average daily frequency of bowel movements, flushing episodes and/or wheezing episodes recorded during the 14-day screening period prior to enrollment in Protocol No. CP-106)\].
- Subject must understand and voluntarily sign the informed consent document.
- Subject must have adequate organ function defined as follows: Absolute granulocyte count (AGC) \>1,500/mm3, hemoglobin \>8 g/dl, platelets \>100,000/mm3, serum bilirubin \<1.5 x upper limit of normal (ULN), serum creatinine \<1.5 mg/dL, SGOT ≤Grade 1 per NCI CTCAE, SGPT ≤Grade 1 per NCI CTCAE.
- Women of child bearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
Exclusion
- Subject who was enrolled in Protocol No. CP-106 and who did not successfully complete 12 treatment cycles.
- If WCBP, pregnant, lactating or not using adequate contraception.
- Clinically relevant active infection or serious co-morbid medical conditions that are uncontrolled or whose control may be jeopardized by atiprimod treatment.
- Psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol.
- Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- As atiprimod is a potent inhibitor of CYP2D6, the use of drugs that are substrates of CYP2D6 (e.g. beta blockers, antidepressants, and antipsychotic;) will not be allowed while on study.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00663429
Start Date
November 1 2007
End Date
March 1 2010
Last Update
August 31 2011
Active Locations (2)
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1
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
2
Mount Sinai Medical Center
New York, New York, United States, 10029