E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic colorectal cancer |
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E.1.1.1 | Medical condition in easily understood language |
Metastatic colorectal cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To assess safety and toxicity (Dose Limiting Toxicity) after intraperitoneal administration of MOC31PE. |
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E.2.2 | Secondary objectives of the trial |
- Overall survival - Progression free survival. - Determine pharmacokinetics and neutralizing anti-immunotoxin antibody response upon intraperitoneal administration of MOC31PE after CRS and HIPEC. - Identify biomarkers of disease recurrence (genomic and proteomic analysis of tumor tissue, normal blood cells and serum/plasma). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically verified EpCAM positive peritoneal carcinomatosis from colorectal cancer - Ambulatory with ECOG performance status 0-1 at the time of surgery - At least 18 years of age - Isolated PC upon radiological work-up. - Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure - PCI ≤20 - Laboratory values: - ANC >= 1.5 x 109/L - Platelets >= 100 x 109/L - Hb >= 9g/dL - Creatinine <= 2x upper limit of normal - Bilirubin < 2.0x the upper limit of normal - ASAT and ALAT <= 2. 5x the upper limit of normal - Albumin levels > 30 g/L - INR<1.3 - Signed informed consent and expected cooperation with respect to treatment and follow-up must be obtained and documented according to ICH GCP, and national/local regulations. |
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E.4 | Principal exclusion criteria |
- Other synchronous metastatic lesions. Patients may be included if they have had curative resection of metastatic CRC disease more than 2 years prior to inclusion and have no relapse at this location is detected. - History of prior other malignant disease the last 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer. - History of CNS or bone metastases - Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia - Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment - BMI > 35 - Any reason why, in the opinion of the investigator, the patient should not participate in the study protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of adverse events and serious adverse events. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) will be used. Changes in laboratory values, vital signs and ECOG performance status will also be assessed. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety profile will be evaluated at each visit. Patient will be hospitalized during 9 days after treatment. Patient will come as outpatient during week 4 and 8 and therafter every 3 months up to 5 years. |
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E.5.2 | Secondary end point(s) |
- Overall survival - Progression free survival - Determine pharmacokinetics and neutralizing anti-immunotoxin antibody response upon intraperitoneal administration of MOC31PE after CRS and HIPEC - Identify biomarkers of disease recurrence (genomic and proteomic analysis of tumor tissue, normal blood cells and serum/plasma). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- up to 5 years after treatment - Every 3 months and up to 5 years - Pharmacokinetic monitoring for 48 hours after MOC31PE administration. Measurement of antibody formation 4 and 8 weeks posttreatment. Serum samples will be collected at 0 h, 3 h, 6 h, 12 h, 24 h, 48 h and at 4 weeks and 8 weeks. - Samples (blood and tissues) collected on day 1 (prior treatment) |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Therapeutic exploratory (phase I/II) |
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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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |