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Metastatic Colorectal CancerPhase 2AMELIONNCT03688230

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

A Phase 2 study testing abituzumab in people with Metastatic Colorectal Cancer, run by SFJ Pharmaceuticals X, LTD..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
abituzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2019to Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent prior to any study specific procedure;
  • Age: ≥18 years;
  • 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;
  • Demonstrated wild-type RAS mutation status in the tumor (primary tumor or metastasis) by local assessment;
  • Tumor tissue specimen shows high ανβ6 integrin expression, as determined by central laboratory assessment;
  • 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);
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  • 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;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  • Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study;

Who cannot join

  • Demonstrated any RAS or BRAF mutation;
  • Prior anti-EGFR or other targeted therapy;
  • Prior chemotherapy of the colorectal cancer, except for (neo) adjuvant therapy completed at least 6 months before randomization;
  • Radiotherapy (localized radiotherapy for pain relief is allowed to non-target lesions);
  • Investigational drug treatment for the treatment of malignancies in the past;
  • Concurrent participation in another interventional clinical study;
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  • Pregnancy (exclusion confirmed with beta-hCG test) or lactation;
  • Any history or evidence of brain metastases or leptomeningeal metastases;
  • 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;
  • 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);
  • 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;
  • Uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg under resting conditions;
  • 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;
  • Recent peptic ulcer disease (endoscopically proven) within 6 months of randomization, chronic inflammatory bowel disease, or acute/chronic ileus;
  • Active infection (requiring IV antibiotics and/or antiviral therapy), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection, AIDS;
  • Presence of any contra-indications or known hypersensitivity to treatment with abituzumab, cetuximab, and FOLFIRI, or to any of the excipients of these drugs;
  • Concomitant treatment with prohibited medications;
  • Medical or psychological conditions that would not permit the patient to complete the study.

About this study

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.

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.

Being tested
abituzumab, Placebo + Cetuximab + FOLFIRI
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abituzumabDrug

    Also called EMD525797

    1000 mg IV

  • Placebo + Cetuximab + FOLFIRICombination product

    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

Study groups in NCT03688230
Study groupRoleWhat they receive
Abituzumab + Cetuximab + FOLFIRIExperimentalCetuximab: 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
Receives: Drug: abituzumab
Placebo + Cetuximab + FOLFIRIPlacebo comparatorCetuximab: 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
Receives: Combination Product: Placebo + Cetuximab + FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression free survival per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.

    Measured: 16 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    The overall survival is defined as the time from randomization to death from any cause.

    Measured: 68 months

  2. Objective Response Rate (ORR)

    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.

    Measured: 16 months

  3. Depth of Response (DPR)

    Depth of response will be estimated as the maximum percent tumor shrinkage during treatment.

    Measured: 16 months

  4. Early Tumor Shrinkage (ETS)

    ETS will be estimated as the proportion of patients achieving a ≥20 % decrease from baseline in the sum of longest tumor diameters.

    Measured: 68 months

  5. Secondary Resection Rate With a Potentially Curative Intent

    Patients for whom the resectability of metastases becomes evident during the study therapy should undergo a surgical resection of the metastases.

    Measured: 16 months

  6. Number of participants with treatment-related adverse events summarized by CTCAE severity grade (v5.0).

    Adverse events will be summarized by body system, preferred term, severity, and relationship to treatment

    Measured: 68 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study startApr 2019 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionAug 2021 (estimated)

Why it stopped: Co-development decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688230
Sponsor's protocol ID
AP218797
Other IDs
2018-003439-31, AIO-KRK-0318/ass, 2018
Acronym
AMELION
Status last verified
Mar 2020
First submitted
24 Sep 2018
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abituzumab in people with Metastatic Colorectal Cancer, run by SFJ Pharmaceuticals X, LTD..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03688230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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