Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
NCT ID: NCT00422786
Last Updated: 2008-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2007-03-31
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.
Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.
Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.
CAP-232 plasma levels were also determined.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAP-232
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
CAP-232
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CAP-232
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Thallion Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thallion Pharmaceuticals Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aline Guillot, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
Damien Pouessel, MD
Role: PRINCIPAL_INVESTIGATOR
CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTP_CAP001
Identifier Type: -
Identifier Source: org_study_id