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Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer. (AMELION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688230
Recruitment Status : Withdrawn (Co-development decision)
First Posted : September 28, 2018
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
SFJ Pharmaceuticals, Inc.
Merck KGaA, Darmstadt, Germany
AIO-Studien-gGmbH
Academic and Community Cancer Research United
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc. ( SFJ Pharmaceuticals X, LTD. )

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: abituzumab Combination Product: Placebo + Cetuximab + FOLFIRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AMELION: A Randomized, Double Blinded, Phase 2, Efficacy and Safety Study of Abituzumab (EMD 525797) in Combination With Cetuximab and FOLFIRI Versus Placebo in Combination With Cetuximab and FOLFIRI in First-line RAS Wild-type, Left-sided, Metastatic Colorectal Cancer Patients With High ανβ6 Integrin Expression.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Abituzumab + Cetuximab + FOLFIRI

Cetuximab:

400 mg/m2 over 120 min followed by 250 mg/m2 weekly 60 min or 500 mg/m2 every two weeks, initially 120 min followed by 60 to 90 min

  • (60 min [± 5 min] after completion of the cetuximab infusion) Abituzumab 1000 mg: every 2 weeks for 60 min
  • (60 min [± 5 min] after completion of the abituzumab infusion) FOLFIRI: every 2 weeks Irinotecan 180 mg/m² IV, 30 - 90 min day 1 Folinic acid (racemic) 400 mg/m² IV, 120 min day 1 5-FU 400 mg/m² bolus day 1 5-FU 2400 mg/m² IV over a period of 46 h day 1-2
Drug: abituzumab
1000 mg IV
Other Name: EMD525797

Placebo Comparator: Placebo + Cetuximab + FOLFIRI

Cetuximab:

400 mg/m2 over 120 min followed by 250 mg/m2 weekly 60 min or 500 mg/m2 every two weeks, initially 120 min followed by 60 to 90 min

  • (60 min [± 5 min] after completion of the cetuximab infusion) Placebo: every 2 weeks for 60 min
  • (60 min [± 5 min] after completion of the placebo infusion) FOLFIRI: every 2 weeks Irinotecan 180 mg/m² IV, 30 - 90 min day 1 Folinic acid (racemic) 400 mg/m² IV, 120 min day 1 5-FU 400 mg/m² bolus day 1 5-FU 2400 mg/m² IV over a period of 46 h day 1-2
Combination Product: Placebo + Cetuximab + FOLFIRI
400 mg/m2 over 120 min followed by 250 mg/m2 weekly 60 min or 500 mg/m2 every two weeks, initially 120 min followed by 60 to 90 min




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 16 months ]
    Progression free survival per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 68 months ]
    The overall survival is defined as the time from randomization to death from any cause.

  2. Objective Response Rate (ORR) [ Time Frame: 16 months ]
    ORR will be estimated as the proportion of responders in each treatment arm, defined as a patient whose best overall response is PR or better during the treatment period according to RECIST 1.1.

  3. Depth of Response (DPR) [ Time Frame: 16 months ]
    Depth of response will be estimated as the maximum percent tumor shrinkage during treatment.

  4. Early Tumor Shrinkage (ETS) [ Time Frame: 68 months ]
    ETS will be estimated as the proportion of patients achieving a ≥20 % decrease from baseline in the sum of longest tumor diameters.

  5. Secondary Resection Rate With a Potentially Curative Intent [ Time Frame: 16 months ]
    Patients for whom the resectability of metastases becomes evident during the study therapy should undergo a surgical resection of the metastases.

  6. Number of participants with treatment-related adverse events summarized by CTCAE severity grade (v5.0). [ Time Frame: 68 months ]
    Adverse events will be summarized by body system, preferred term, severity, and relationship to treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated written informed consent prior to any study specific procedure;
  2. Age: ≥18 years;
  3. Evidence of newly diagnosed stage IV metastatic colorectal cancer. Primary tumor location on the left side of the Colon (including left splenic flexure) or rectum;
  4. Demonstrated wild-type RAS mutation status in the tumor (primary tumor or metastasis) by local assessment;
  5. Tumor tissue specimen shows high ανβ6 integrin expression, as determined by central laboratory assessment;
  6. Tumor tissue specimen (formalin-fixed, paraffin-embedded block) preferably from primary resection and/or if available from a surgical sample from metastatic site must be available for central laboratory based ανβ6 integrin expression analysis. (No Fine Needle Aspiration [FNA] will be accepted);
  7. At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST (Version 1.1), 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;
  8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  9. Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study;

Exclusion Criteria:

  1. Demonstrated any RAS or BRAF mutation;
  2. Prior anti-EGFR or other targeted therapy;
  3. Prior chemotherapy of the colorectal cancer, except for (neo) adjuvant therapy completed at least 6 months before randomization;
  4. Radiotherapy (localized radiotherapy for pain relief is allowed to non-target lesions);
  5. Investigational drug treatment for the treatment of malignancies in the past;
  6. Concurrent participation in another interventional clinical study;
  7. Pregnancy (exclusion confirmed with beta-hCG test) or lactation;
  8. Any history or evidence of brain metastases or leptomeningeal metastases;
  9. History of secondary malignancy within the past 5 years, except for basal cell carcinoma or carcinoma in situ of the cervix uteri, if treated with curative intent;
  10. Concomitant chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement; steroids up to 10 mg per day of prednisone equivalent or topical and inhaled steroids are allowed);
  11. Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), or clinically relevant cardiomyopathy;
  12. Uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg under resting conditions;
  13. History of myocardial infarction in the last 12 months, or a high risk of uncontrolled arrhythmia, coagulation disorder associated with bleeding or recurrent thrombotic events, with the exception of arterial fibrillation treated with anti-coagulants;
  14. Recent peptic ulcer disease (endoscopically proven) within 6 months of randomization, chronic inflammatory bowel disease, or acute/chronic ileus;
  15. Active infection (requiring IV antibiotics and/or antiviral therapy), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection, AIDS;
  16. Presence of any contra-indications or known hypersensitivity to treatment with abituzumab, cetuximab, and FOLFIRI, or to any of the excipients of these drugs;
  17. Concomitant treatment with prohibited medications;
  18. Medical or psychological conditions that would not permit the patient to complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688230


Sponsors and Collaborators
SFJ Pharmaceuticals X, LTD.
SFJ Pharmaceuticals, Inc.
Merck KGaA, Darmstadt, Germany
AIO-Studien-gGmbH
Academic and Community Cancer Research United
Investigators
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Principal Investigator: Dirk Arnold, Prof. Dr. Asklepios Tumorzentrum Hamburg
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Responsible Party: SFJ Pharmaceuticals X, LTD.
ClinicalTrials.gov Identifier: NCT03688230    
Other Study ID Numbers: AP218797
2018-003439-31 ( EudraCT Number )
AIO-KRK-0318/ass ( Other Identifier: AIO-Studien-gGmbH )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents