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Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

NCT03339843 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-03-15

No results posted yet for this study

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.

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

Conditions

Interventions

DRUG

Abemaciclib

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.

Sponsors & Collaborators

Principal Investigators

  • Laura Polastro, MD · Jules Bordet Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2021-11-12
Completion
2023-12-20

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339843 on ClinicalTrials.gov