metastatic kidney cancer MedDRA version: 8.1 Level: LLT Classification code 10023405 Term: Kidney cancer stage IV
Conditions
Interventions
Product Name: CAP 232
Product Code: CAP 232
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: synthetic peptide CAP-232 acetate
Other descriptive name: formerly known as
Sponsors
Caprion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must have histologically confirmed stage IV kidney clear cell carcinoma. 2) Patients must have progressive disease after receiving a previous systemic therapy. 3) Patient must have progressive disease confirmed by 2 CT Scans or MRI performed within 6 months. 4) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. 5) Patients must have an age >18 years. 6) Patients must have life expectancy of greater than 3 months. 7) Patient must be 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. 8) Patients must have ECOG performance status ? ?2 (Karnofsky 60%). 9) Patients must have normal organ and marrow function as defined below: • Leukocytes >3,000/mm3 • Absolute neutrophil count >1,500/mm3 • Platelets >100,000/ mm3 • Total bilirubin within normal institutional limits • AST(SGOT)/ALT(SGPT) ?2.5 X institutional upper limit of normal • Calculated creatinine clearance >30 mL/min/1.73 m2 10) Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 11) Patients or the patient’s legal guardian must be able to understand and have the willingness to sign a written informed consent document. 12) Patients must have the ability to receive central vein access catheter and manage an infusion pump. 13) Women of child bearing potential must have a negative serum pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 11) Patients who have received any known medical treatment targeting cancer within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2) Patients may not be receiving any other investigational agents at least 30 days prior to enrollment in the study or/and participate in another clinical trial. 3) Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 4) Patients with a history of allergic reactions attributed to compounds of similar composition to CAP-232. CAP-232 consists of a heptapeptide (active ingredient) in an acetate buffered saline solution with mannitol (0.2 M sodium acetate, 0.2 M acetic acid, 3% mannitol). 5) Patient with 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 10 years 6) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 7) Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAP-232, breastfeeding should be discontinued if the mother is treated with CAP-232. 8) Patients that have previously been enrolled into this study and subsequently withdrawn must also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of CAP-232 as a monotherapy (each 28-day cycle consists of 21 days continuous IV infusion of CAP-232 at 0.5 mg/kg/day followed by a 7-day rest period) in patients with metastatic kidney cancer. The primary efficacy parameter will be the response rate based on RECIST criteria.;Secondary Objective: Secondary objectives include: • 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) ;Primary end point(s): The primary safety endpoints will include the occurrence of AEs, clinical laboratory parameters, vital signs, ECGs and physical examination variables. The primary efficacy endpoints will: - determine the M2PK plasma levels during the course of treatment - determine disease state using RECIST criteria at the end of 2 cycles - determine progression-free survival rate - determine time to progression and overall survival Other endpoints will: - evaluate the quality of life during each cycle - determine the pharmacokinetic (PK) characteristics of CAP-232 - determine potential blood and/or urine biomarkers for predicting efficacy | — |
Countries
France
Outcome results
None listed