Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: CAP-232


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAP-232<br>Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. | Drug: CAP-232<br>* Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period<br>* Other names: TLN-232;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Clear Cell Renal Cell Carcinoma, Phase II, Thallion, TLN-232, CAP-232, M2PK