Status:
COMPLETED
Multiorgan Metabolic Imaging Response Assessment of Abemaciclib
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Esophageal Adenocarcinoma
Esophagus SCC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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-...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03339843
Start Date
December 19 2018
End Date
December 20 2023
Last Update
March 15 2024
Active Locations (11)
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1
Universitair Ziekenhuis
Antwerp, Belgium
2
Institut Jules Bordet
Brussels, Belgium, 1000
3
Algemeen Ziekenhuis Groeninge
Kortrijk, Belgium, 8500
4
CHC Saint-Joseph
Liège, Belgium, 4000