Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
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
1 other identifier
interventional
10
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2007
Shorter than P25 for phase_2
2 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
First Submitted
Initial submission to the registry
January 12, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJuly 15, 2008
July 1, 2008
1 year
January 12, 2007
July 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Secondary Outcomes (5)
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)
Study Arms (1)
CAP-232
EXPERIMENTALContinuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
Interventions
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
Eligibility Criteria
You may qualify if:
- Histologically confirmed stage IV kidney clear cell carcinoma.
- Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
- Measurable disease
- Age \>18 years.
- Life expectancy of greater than 3 months.
- At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
- ECOG performance status 2 or lower (Karnofsky 60%).
- Normal organ and marrow function
- Adequate contraception prior to study entry and for the duration of study participation.
- Ability to understand and have the willingness to sign a written informed consent document.
- Ability to receive central vein access catheter and manage an infusion pump.
- Women of child bearing potential must have a negative serum pregnancy test.
You may not qualify if:
- Anti-cancer therapy within 4 weeks prior to entering the study
- Investigational agents less than 30 days prior to enrollment in the study.
- Known brain metastases
- History of allergic reactions attributed to compounds of similar composition to CAP-232.
- Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
- Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
- Breastfeeding
- Patients previously enrolled into this study and subsequently withdrawn
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, 34298, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, France
Related Publications (3)
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.
PMID: 17094470BACKGROUNDTejeda 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.
PMID: 16886628BACKGROUNDGyergyay 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aline Guillot, MD
Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
- PRINCIPAL INVESTIGATOR
Damien Pouessel, MD
CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France
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
January 12, 2007
First Posted
January 17, 2007
Study Start
March 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 15, 2008
Record last verified: 2008-07