Safety and Efficacy Study of PTK787/ZK222584 to Treat Metastatic Neuroendocrine Tumors (PTK787)
|ClinicalTrials.gov Identifier: NCT00590343|
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : June 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Neuroendocrine Tumors||Drug: vatalanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase II Study Evaluating the Safety and Efficacy of PTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms.|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||October 2010|
Intervention=Patients will receive treatment with PTK787/ZK222584 daily. A treatment cycle will be defined as a 28-day period. Subjects will continue on their present treatment regimen of receiving Sandostatin LAR 30mg IM every 4 weeks.
Subjects who meet all inclusion and exclusion criteria will receive an initial dose of PTK787/ZK222584 1,250mg once daily, and subjects will remain on the scheduled doses of Sandostatin LAR 30mg every 4 weeks.
- Change in biochemical markers. [ Time Frame: Quarterly= every 3 months ]
- Tumor response per triphasic CT scan. [ Time Frame: Quarterly= every 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590343
|United States, Louisiana|
|Kenner, Louisiana, United States, 70065|
|Principal Investigator:||Lowell B Anthony, MD||Lousiana State University Health Sciences Center-NO|