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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01008475
Other study ID # EMR62242-004
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received October 19, 2009
Last updated August 7, 2015
Start date October 2009
Est. completion date April 2015

Study information

Verified date August 2015
Source Merck KGaA
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeRussia: Ministry of Health of the Russian FederationPoland: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsIsrael: Israeli Health Ministry Pharmaceutical AdministrationIsrael: Ministry of HealthHungary: National Institute of PharmacyHungary: Scientific and Medical Research Council Ethics CommitteeGreece: Ethics CommitteeGreece: National Organization of MedicinesCyprus: Cyprus National Bioethics CommitteeBulgaria: Bulgarian Drug AgencyBulgaria: Ethics committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting α v integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.


Recruitment information / eligibility

Status Terminated
Enrollment 229
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis;

- Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease;

- Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment;

- At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as >=2 centimeter (cm) by conventional techniques or >=1 cm by spiral CT scan;

- Eastern Cooperative Oncology Group (ECOG) performance status 0 1, or KPS >=80%;

- Absolute Neutrophil Count(ANC) >=1.5 x 10^9/L;

- Platelets >=100 x 10^9/L;

- Hemoglobin >=9 g/dL (without transfusions);

- Bilirubin <=1.5 x ULN;

- ASAT <=5 x ULN and ALAT <=5 x ULN;

- Serum creatinine <=1.25 x Upper limit of normal (ULN) and/or creatinine clearance >=50 ml/min;

- International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits;

- Sodium and potassium within normal limits or =10% above or below (supplementation permitted);

Exclusion Criteria:

- Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (EGFR);

- Known brain metastasis and/or leptomeningeal disease;

- Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry; planned major surgery during the trial;

- Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed);

- Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia;

- Uncontrolled hypertension defined as systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg under resting conditions;

- History of coagulation disorder associated with bleeding or recurrent thrombotic events;

- History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start;

- Chronic inflammatory bowel disease, or acute/chronic ileus;

- Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
EMD 525797, Irinotecan and Cetuximab
Arm A: EMD 525797 (target dose: 500 mg) every 2 weeks + cetuximab 400 mg/m2, Day 1 Cycle 1, and afterwards 250 mg/m2 weekly + irinotecan 180 mg/m2 every 2 weeks
EMD 525797, Irinotecan and Cetuximab
Arm B: EMD 525797 (target dose: 1,000 mg or as defined by SMC) every 2 weeks + cetuximab 400 mg/m2, Day 1 Cycle 1, and afterwards 250 mg/m2 weekly + irinotecan 180 mg/m2 every 2 weeks
Drug:
Irinotecan and Cetuximab
Arm C: Cetuximab 400 mg/m2, Day 1 Cycle 1, and afterwards 250 mg/m2 weekly + irinotecan 180 mg/m2 every 2 weeks

Locations

Country Name City State
Belgium Research Site Brussels
Belgium Research Site Edegem
Belgium Research Site Gent
Belgium Research Site Leuven
Bulgaria Research Site Sofia
Cyprus Research Site Strovolos Nicosia
Czech Republic Research Site Brno
Czech Republic Research Site Horovice
Czech Republic Research Site Kutna Hora
Czech Republic Research Site Olomouc
Czech Republic Research Site Pardubice
Czech Republic Research Site Prague
Germany Research Site Dresden
Germany Research Site Essen
Germany Research Site Freiburg
Germany Research Site Hamburg
Germany Research site Hannover
Germany Research Site Heilbronn
Germany Research Site Landshut
Germany Research Site Leipzig
Germany Research Site Munich
Germany Research Site Recklinghausen
Germany Research Site Ulm
Greece Research Site Mournies Chania
Greece Research Site Thessaloniki Cyprus
Hungary Research Site Budapest
Hungary Research Site Gyor
Hungary Research Site Kecskemet
Hungary Research Site Miskolc
Hungary Research Site Nyiregyhaza
Hungary Research Site Szolnok
Israel Research Site Haifa
Israel Research Site Jerusalem
Israel Research Site Ramat Gan
Israel Research Site Rechovot
Israel Research Site Tel-Aviv
Poland Research Site Elblag
Poland Research Site Gdansk
Poland Research Site Gliwice
Poland Research Site Lódz
Poland Research Site Rybnik
Poland Research Site Warszawa
Russian Federation Research Arkhangelsk
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Omsk
Russian Federation Research Site St. Petersburg
Russian Federation Research Site Tomsk
Spain Research Site Barcelona
Spain Research Site Elche
Spain Research Site Madrid
Spain Research Site Mallorca
Spain Research Site Santander
Spain Research Site Santiago de Compostela
Spain Research Site Terrassa
Spain Research Site Valencia
United Kingdom Research Site Aberdeen
United Kingdom Research Site Glasgow
United Kingdom Research Site London
United Kingdom Research Site Manchester
United Kingdom Research Site Nottingham
United Kingdom Research Site Sutton

Sponsors (1)

Lead Sponsor Collaborator
Merck KGaA

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Cyprus,  Czech Republic,  Germany,  Greece,  Hungary,  Israel,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary endpoint of Safety Part: Number and proportion of subjects experiencing DLTs (dose limiting toxicity) using the NCI-CTCAE Version 3.0 in each dose level over the first 2 weeks after first drug intake the first 2 weeks after first drug intake (14 days) Yes
Primary Primary endpoint of Randomised Part: The Progression free survival (PFS) hazard ratio of each experimental treatment over standard of care arm. Time from randomization until radiological progressive disease confirmed by investigator or all cause death No
Secondary To further evaluate the efficacy of 2 EMD 525797 doses with respect to overall survival (OS) time Time from randomization to death No
Secondary To further evaluate the efficacy of 2 EMD 525797 doses with respect to time to progression (TTP) Time from randomization to progression No
Secondary To further evaluate the efficacy of 2 EMD 525797 doses with respect to tumor response (RECIST criteria [Version 1.0]) Time from randomization to confirmed response No
Secondary To further evaluate the efficacy of 2 EMD 525797 doses with respect to time to treatment failure (TTF) Time from randomization to treatment discontinuation for any reason No
See also
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