Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
A Phase II Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
2 other identifiers
interventional
55
1 country
8
Brief Summary
This study will evaluate 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2006
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 21, 2007
December 1, 2007
October 11, 2006
December 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction of symptoms (diarrhea, flushing and/or wheezing)
1 year
Progression of neuroendocrine tumor(s)
1 year
Secondary Outcomes (1)
Adverse events
1 year
Interventions
oral, 14 days on / 14 days off; 30mg capsules
Eligibility Criteria
You may qualify if:
- Patient must have documented histologic proof of low or intermediate grade neuroendocrine carcinoma. Both carcinoid (any site; atypical/intermediate grade carcinoid is allowed) and islet cell (pancreatic endocrine tumor) will be eligible. Patient with neuroendocrine tumors associated with MEN1 syndrome will be eligible.
- Patients must have either metastatic or unresectable local-regional cancer. Patients with brain metastases are allowed on study, but they must have evaluable target lesions elsewhere.
- Patients must have measurable disease, as defined by RECIST.
- Patients must 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
Cedars Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern
Chicago, Illinois, 60611, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Scott and White Memorial Hospital, Scott Sherwood and Brindley Facility
Temple, Texas, 76508, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gary Jacob, Ph.D.
Callisto Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 13, 2006
Study Start
October 1, 2006
Study Completion
September 1, 2007
Last Updated
December 21, 2007
Record last verified: 2007-12