Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003672

Trial Description

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Title

An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line Treatment for Subjects With K-ras Wild Type Metastatic Colorectal Cancer.

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Trial Acronym

POSEIDON

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003672
  •   2012/05/03
  •   2009/10/19
  •   no
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Secondary IDs

  •   NCT01008475  (ClinicalTrials.gov)
  •   EMR62242-004  (Merck KGaA)
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Health Condition or Problem studied

  •   Metastatic Colorectal Cancer
  •   C20 -  Malignant neoplasm of rectum
  •   C18 -  Malignant neoplasm of colon
  •   C21 -  Malignant neoplasm of anus and anal canal
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Interventions/Observational Groups

  •   Biological: EMD 525797, Irinotecan and Cetuximab
  •   Biological: EMD 525797, Irinotecan and Cetuximab
  •   Drug: Irinotecan and Cetuximab
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   I-II
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Primary Outcome

- 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; time frame: the first 2 weeks after first drug intake (14 days)
- Primary endpoint of Randomised Part: The Progression free survival (PFS) hazard ratio of each experimental treatment over standard of care arm.; time frame: Time from randomization until radiological progressive disease confirmed by investigator or all cause death

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Secondary Outcome

- To further evaluate the efficacy of 2 EMD 525797 doses with respect to overall survival (OS) time; time frame: Time from randomization to death
- To further evaluate the efficacy of 2 EMD 525797 doses with respect to time to progression (TTP); time frame: Time from randomization to progression
- To further evaluate the efficacy of 2 EMD 525797 doses with respect to tumor response (RECIST criteria [Version 1.0]); time frame: Time from randomization to confirmed response
- To further evaluate the efficacy of 2 EMD 525797 doses with respect to time to treatment failure (TTF); time frame: Time from randomization to treatment discontinuation for any reason

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Countries of Recruitment

  •   Belgium
  •   Bulgaria
  •   Cyprus
  •   Czech Republic
  •   Germany
  •   Greece
  •   Hungary
  •   Israel
  •   Poland
  •   Russian Federation
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2009/10/31
  •   228
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Subjects with histologically confirmed k ras 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 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 10E9/L;

- Platelets ≥100 x 10E9/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);

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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

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Addresses

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    • Merck KGaA
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    • Merck KGaA
    • Ilona Rybicka, MD 
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    • Merck KGaA
    • Ilona Rybicka, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.