A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer
Sponsor study identifier
interventional
10
1 country
2
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 12, 2007
Actual (reported)January 17, 2007
Actual (reported)March 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 2008
Actual (reported)March 2008
Actual (reported)The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Safety (through clinical and biological evaluations)
Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
Pharmacokinetic (PK) characteristics of the first 15 recruited patients
Quality of life
Biological modulation (through potential blood and/or urine biomarkers including M2PK)
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, 34298, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, France
Tejeda M, Gaal D, Hullan L, Hegymegi-Barakonyi B, Keri G. Evaluation of the antitumor efficacy of the somatostatin structural derivative TT-232 on different tumor models. Anticancer Res. 2006 Sep-Oct;26(5A):3477-83.
Tejeda M, Gaal D, Hullan L, Csuka O, Schwab R, Szokoloczi O, Keri G. A comparison of the tumor growth inhibitory effect of intermittent and continuous administration of the somatostatin structural derivative TT-232 in various human tumor models. Anticancer Res. 2006 Jul-Aug;26(4B):3011-5.
Aline Guillot, MD
Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
Damien Pouessel, MD
CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France
10 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2007
First Posted
January 17, 2007
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
LBH589 Treatment for Refractory Clear Cell Renal Carcinoma
Contact the study team to confirm eligibility.
Gyergyay F, Gödény M, Sármay G, Kralovanszky J, Papp E, Gergye M, Vincze B, Kéri G, Bodrogi I : Antitumor activity and pharmacology of TT-232 (a novel somatostatin structural derivative) in malignant melanoma patients JCO, 2004 ASCO Annual Meeting Proceedings Vol 22, No 14S (July 15 Supplement), 2004: 3151
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
July 15, 2008
Record last verified: 2008-07
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Source: ClinicalTrials.gov.
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