E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023405 |
E.1.2 | Term | Kidney cancer stage IV |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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In the absence of treatment delays due to adverse event(s), treatment may continue for 12 cycles or until one of the following criteria applies: • Disease progression, • Intercurrent illness that prevents further administration of treatment, • Unacceptable adverse event(s), • Patient decides to withdraw from the study, or • General or specific changes in the patient’s condition render the patient unacceptable for further treatment in the judgment of the investigator.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 30 |