Condition
Solid Tumour,|Breast Cancer,|Metastatic Melanoma,|Non-small Cell Lung Cancer (NSCLC),
Estimated Enrollment: 96
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: PH-F16IL2TAXO-05/07|2007-006457-42
Study First Received: May 25, 2010
Last Updated: October 20, 2014
Estimated Primary Completion Date: May 2015
Primary Outcome Measures:
To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with paclitaxel (Phase I).|To investigate the efficacy of F16IL2, in terms of objective response rate in combination with paclitaxel in metastatic melanoma, breast cancer and NSCLC patients amenable to taxane therapy (Phase II)|To investigate the safety and tolerability of F16IL2 and paclitaxel when given as a combination (Phase I/II).|Investigate pharmacokinetics of F16IL2 and paclitaxel when given as a combination.|Human anti-fusion protein antibodies|Antitumor activity|Assessment of median progression-free survival and median overall survival.
Sponsors and Collaborators:
Philogen S.p.A.
Website Link: https://ClinicalTrials.gov/show/NCT01134250
