Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
Primary Purpose
Carcinoma, Renal Cell
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
CAP-232
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Refractory Clear Cell Renal Cell Carcinoma, Phase II, Thallion, TLN-232, CAP-232, M2PK
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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- Patients previously enrolled into this study and subsequently withdrawn
Sites / Locations
- CRLC Val d'Aurelle Paul-Lamarque
- Institut de Cancérologie de la Loire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAP-232
Arm Description
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
Outcomes
Primary Outcome Measures
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00422786
First Posted
January 12, 2007
Last Updated
July 10, 2008
Sponsor
Thallion Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00422786
Brief Title
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Thallion Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Refractory Clear Cell Renal Cell Carcinoma, Phase II, Thallion, TLN-232, CAP-232, M2PK
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAP-232
Arm Type
Experimental
Arm Description
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
Intervention Type
Drug
Intervention Name(s)
CAP-232
Other Intervention Name(s)
TLN-232
Intervention Description
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
Primary Outcome Measure Information:
Title
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Secondary Outcome Measure Information:
Title
Safety (through clinical and biological evaluations)
Title
Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
Title
Pharmacokinetic (PK) characteristics of the first 15 recruited patients
Title
Quality of life
Title
Biological modulation (through potential blood and/or urine biomarkers including M2PK)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline Guillot, MD
Organizational Affiliation
Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Damien Pouessel, MD
Organizational Affiliation
CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRLC Val d'Aurelle Paul-Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
St-Priest en Jarez
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17094470
Citation
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.
Results Reference
background
PubMed Identifier
16886628
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Learn more about this trial
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
We'll reach out to this number within 24 hrs