A Phase II Open-Label Extension Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
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 bidimensionally measurable disease. In the more recently reported ECOG phase
III study of chemotherapy in carcinoid tumors (E1281), patients were randomly assigned to
treatment with 5-fluorouracil (5FU) plus doxorubicin or 5FU plus streptozocin. The median
progression free survival durations were disappointing. They were 4.5 months in the 5FU plus
doxorubicin arm and 5.3 months in the 5FU plus streptozocin arm. Overall survival durations
recorded in the trial were also suboptimal at 15 and 24 months respectively. There is no
clear survival benefit for cytotoxic chemotherapy.
This is a phase II, multi-center, open-label extension study of the safety and efficacy of
atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who
have metastatic or unresectable local-regional cancer and who have either symptoms
(diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of
neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20%
increase in the sum of the longest diameter of target lesions during the 6 months prior to
enrollment in CP-106). Atiprimod will be administered orally as a single daily dose of 60
mg/day for 14 days, followed by a 14-day treatment-free period (i.e., 1 treatment cycle = 28
days).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction of symptoms (diarrhea, flushing and/or wheezing)
1 year
No
Gary S Jacob, PhD
Study Director
Callisto Pharmaceuticals
United States: Food and Drug Administration
CP-AT202-07
NCT00663429
November 2007
March 2010
Name | Location |
---|---|
Mount Sinai Medical Center | New York, New York 10029 |
Hematology Oncology Services of Arkansas | Little Rock, Arkansas 72205 |