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Esophageal AdenocarcinomaPhase 2MiMe-ANCT03339843

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

A Phase 2 study testing Abemaciclib in people with Esophageal Adenocarcinoma and Esophagus SCC, run by Jules Bordet Institute at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abemaciclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
11 sitesin 2 countries
Study dates
19 Dec 2018to 20 Dec 2023
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

  • Age ≥ 18 years old
  • Female or male
  • ECOG performance status ≤ 1
  • Life expectancy of greater than 12 weeks
  • Must have histologically confirmed cancer corresponding to the predefined tumour subtypes (esophageal adenocarcinoma, esophageal squamous cell carcinoma, cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), endometrial cancer) and metastatic or non-resectable and refractory to standard platinum regimens (and progressive after immunotherapy for the urothelial cancer).
  • Presence of at least one metabolically measurable tumour lesion on FDG-PET/CT, according to PERCIST. If previously irradiated, must have been more than 2 months before the baseline FDG PET/CT.
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  • Measurable disease according to RECIST v 1.1
  • Serum pregnancy test (for subjects of childbearing potential) negative
  • Women of childbearing potential must agree to the use a highly effective method of contraception prior to study entry, during the course of the study and at least 3 months after the last administration of study treatment.
  • Men with childbearing potential partner must agree to use condom during the course of this study and for at least 3 months after the last administration of the study treatment.
  • Adequate coagulation: International Normalized Ratio (INR) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as INR and activated partial thromboplastin time [aPTT] are within therapeutic range of intended use of anticoagulants
  • Adequate bone marrow function as defined below:
  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1500/µL or 1.5x109/L
  • Platelets ≥ 100000/µL or 100x109/L
  • Leukocytes ≥ 3,000/µL
  • Adequate liver function as defined below:
  • Serum total bilirubin within 1.5 × normal institutional limits (except for Gilbert syndrome where direct bilirubin should be <1.5 institutional ULN)
  • AST/ALT/ALP) levels < 3 × institutional upper limit of normal (or ALT and AST <5 times upper limit of normal if liver metastases are present).
  • Adequate renal function as defined below: Cockcroft-Gault creatine clearance >50ml/min
  • Completion of all necessary screening procedures
  • Ability to swallow capsules
  • Grade ≤ 1 toxicity due to any previous cancer therapy according to the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE, v.4.03). Grade 2 is allowed in case of alopecia and peripheral sensory neuropathy
  • Availability of primary archived tumour tissue block (1 FFPE tumour tissue)
  • Signed Informed Consent form (ICF) obtained prior to any study related procedure

Who cannot join

  • Subjects meeting one of the following criteria are not eligible for this studyParticipants who have had chemotherapy, radiotherapy, immunotherapy, or targeted therapy within 3 weeks prior study enrolment
  • Participants receiving concomitantly any other experimental agents
  • Patients who have received prior therapy with other CDK4/6 inhibitors
  • Subjects with known brain metastasis; unless the metastasis are asymptomatic and have been stable since at least 2 months prior to treatment start.
  • Patient with meningeal carcinomatosis
  • Have had major surgery within 28 days prior to the start of the treatment to allow for post-operative healing of the surgical wound
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition
  • Bleeding diathesis, thromboembolic event, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months
  • Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
  • Substance abuse, psychiatric illness/social situations, any psychological, familial, sociological, geographical condition, significant medical or surgical condition currently uncontrolled by treatment that would limit compliance with study requirements or interfere with the patient's ability to understand informed consent and participation in the study
  • Pregnant and/or lactating women
  • Uncontrolled Diabetes
  • Known history of HIV infection, or active hepatitis B or C requiring treatment with anti-viral therapy
  • Have received recent (within 28 days prior the enrolment) yellow fever vaccination
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free and are deemed by the investigator to be at low risk for recurrence of that malignancy.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Belgium6 sites

  • Universitair Ziekenhuis

    Antwerp

  • Institut Jules Bordet

    Brussels, 1000

  • Algemeen Ziekenhuis Groeninge

    Kortrijk, 8500

  • CHC Saint-Joseph

    Liège, 4000

  • CHU Ambroise Paré

    Mons, 7000

  • CHU UCL Namur Sainte-Elisabeth

    Namur, 5000

Other trials in Belgium

France5 sites

  • Centre Oscar Lambret

    Lille, 59000

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Centre Henri Becquerel

    Rouen, 76038

  • Hôpital universitaire de Strasbourg - ICANS

    Strasbourg, 67000

  • IUCT Oncopole - Institut Claudius Regaud

    Toulouse, 31059

Other trials in France

About this study

Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.

Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage:

  1. Platinum-refractory esophageal adenocarcinoma (ADC)
  2. Platinum-refractory esophageal squamous cell carcinoma (SCC)
  3. Platinum-refractory cholangiocarcinoma
  4. Platinum-refractory and progressive after immunotherapy urothelial cancer
  5. Platinum-refractory endometrial cancer
Read the detailed description

In various solid tumour types FDG-PET/CT has been shown to identify treatment-refractory diseases with a high negative predictive value (NPV) through a whole-body quantitative assessment of treatment-induced changes in tumour glucose uptake soon after treatment initiation, before any structural changes are observed. Progress in the standardisation of FDG-PET/CT imaging and response analysis now allow its use in multicentric trials opening the possibilities for trials where treatment allocation will be based on early metabolic response. MiMe has been built on the assumption that a medication which does not induce any metabolic changes in a given clinical setting is unlikely to induce a significant benefit and does consequently not deserve further investigation as a single agent in this setting.

MiMe, by assessing metabolic response early during the treatment course, will hopefully provide useful information about the drug activity in various cancer types, and about mechanisms of resistance through a potential ambitious translational research program with serial collection of circulating-tumour DNA (ct-DNA).

Being tested
Abemaciclib
Keywords
cancer
Medical subject headings
Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Cholangiocarcinoma, Urologic Neoplasms, Endometrial Neoplasms, Neoplasms

What participants receive

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

  • AbemaciclibDrug

    Also called FDG-PET/CT

    Subjects will receive 200 mg of abemaciclib orally, two times a day, during cycles of 28 days each. An early FDG-PET/CT will be performed at cycle 1 day 14 to search for any new lesions.

Study groups in NCT03339843
Study groupRoleWhat they receive
AbemaciclibExperimentalThis study contains 2 stages; during the 1st stage, a maximum of 17 patients will be enrolled in each tumour type cohort. After 13 evaluable patients have been enrolled, an interim analysis will be performed. If 3 or more patients are seen to have experienced a treatment success, then the cohort will pass into the 2nd stage in which a maximum of 20 more patients are enrolled. If 2 or less patients are seen to have experienced a treatment success, then that cohort will be closed and will not proceed into the 2nd stage. Subjects will receive 200 mg of abemaciclib orally, twice a day, during cycles of 28 days each. The subject will undergo: A baseline FDG-PET/CT and a baseline CT scan and A blinded early FDG-PET/CT at D14 +/- 2 days of study treatment. A treatment success is defined as a patient who has metabolic response according to PERCIST with a response cut off set at 15% at the early FDG-PET/CT and a morphological disease control after 2 cycles measured by RECIST v1.1.
Receives: Drug: Abemaciclib

What is being measured

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

  1. Evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using FDG-PET/CT during the first cycle of therapy (early FDG- PET/CT).

    Therapy success rate defined as: PERCIST 15%-assessed Metabolic Response at early FDG-PET/CT (D12-D16)

    Measured: 2 months

  2. Evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using RECISTv1.1 after 2 cycles of therapy as a screening tool.

    Therapy success rate defined as: RECISTv1.1-assessed Disease Control (DC) after 2 treatment cycles (CR or PR or SD)

    Measured: 2 Months

Secondary outcomes (6)

  1. Evaluate Progression-free survival (PFS define as the time from treatment start until disease progression or death) at 24 weeks from treatment start

    RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the PFS

    Measured: 6 months

  2. Evaluate Overall Survival (OS defined as the time from treatment start until death) at 24 weeks from treatment start

    RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the OS.

    Measured: 6 months

  3. To evaluate median progression-free survival (PFS)

    Progression Free Survival

    Measured: 42 months

  4. Evaluate median overall survival (OS)

    Overall Survival

    Measured: 42 months

  5. To evaluate toxicity profile

    Toxicity profile according to CTCAE version 4.03

    Measured: 6 months

  6. Evaluate the correlation of early metabolic response using FDG-PET/CT with morphological response to treatment assessed by RECIST

    RECIST v1.1-based radiological response assessment performed at 24 weeks from the treatment start to determine the PFS and OS

    Measured: 6 months

Timeline

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

  1. First posted13 Nov 2017
  2. Study start19 Dec 2018
  3. Primary completion12 Nov 2021
  4. Study completion20 Dec 2023

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
Not applicable
Intervention model
Sequential
Model description
This is a two step, open-label, basket trial looking at 5 different tumour types.
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03339843
Sponsor's protocol ID
IJB-MULTI-MIME-A-2017
Acronym
MiMe-A
Status last verified
Jul 2023
First submitted
5 Oct 2017
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib in people with Esophageal Adenocarcinoma and Esophagus SCC, run by Jules Bordet Institute at 11 sites in 2 countries.

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 25 inclusion and 15 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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using FDG-PET/CT during the first cycle of therapy (early FDG- PET/CT). (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT03339843.

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 15 Mar 2024.

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