Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer

NCT04030429 | Terminated Phase 2

• 1 other identifier: B-BR-108-016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of endometrial cancer patients with disease spread beyond the uterus will progress within 1 year. Platinum-based chemotherapy was used as the first-line treatment in metastatic or advanced endometrial cancer. There is no standard protocol for the second-line option when tumors persist or recur. In vitro and in vivo studies showed Crizotinib, an approved drug for the treatment of ALK-positive non-small cell lung cancer, demonstrated activities in endometrial cancer with c-MET kinase and Sema domain mutations. As a consequence, a phase 2 clinical trial to investigate the efficacy of Crizotinib in endometrial cancer patients with MET mutation is initiated.

Conditions

Endometrial Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Change in best overall response rate

  CT scan or MRI will be used to evaluate the response every 2 cycles according to the RECIST 1.1 criteria. The best overall response rate is the proportion of patients in whom a complete response (CR) or partial response (PR) was observed.

  CT scan or MRI will be done at baseline and at the end of every 2 cycles (each cycle is 28 days) until the date of first documented progression or date of death from any cause, whichever came first, up to 104 weeks

Secondary Outcomes (2)

• Progression-free survival

  CT scan or MRI will be done at baseline and at the end of every 2 cycles (each cycle is 28 days) until the date of first documented progression or date of death from any cause, whichever came first, up to 104 weeks

• Overall survival

  Overall survival will be followed from the start of treatment to death from any cause, up to 104 weeks

Study Arms (1)

Crizotinib arm

EXPERIMENTAL

Crizotinib 250 mg bid orally

Drug: Crizotinib 250 MG

Interventions

Crizotinib 250 MG DRUG

bid orally

Also known as: Xalkori 250 MG

Crizotinib arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age no less than 20 years and no more than 75 years, at the time of acquisition of informed consent.
• Histological confirmed epithelial endometrial cancer
• Disease recurrent after curative therapy or adjuvant therapy including surgery, chemotherapy, radiotherapy or hormone therapy
• Metastatic/recurrent/persistent endometrial cancer
• Tumor tissue with high expression in immunohistochemistry stain (IHC) or somatic c-MET mutation
• Patients with symptomatic recurrent lesion or Image diagnosis (including ultrasound, Computed Tomography or Magnetic Resonance Imaging) recurrent status
• ECOG Performance status 0-2
• At least one distinct tumor, not previous irradiated, measurable lesion according to RECIST (version 1.1)
• Adequate organ function
• Bone marrow:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L WBC ≥ 3.0 x 10\^9/L Platelet count ≥ 100 x 10\^9/L Hemoglobin ≥ 9 g/dL
• Hepatic:
• Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL Renal: Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula)
• Negative pregnancy test for women of childbearing potential only
• Patient willing to provide blood sample for research purposes

You may not qualify if:

• Presence or history of malignancy disease other than endometrial cancer that has been diagnosed with past five years
• Other anti-tumor agent such as systemic chemotherapy, hormone therapy or surgery within 2 weeks before the commencement of study treatment or radiotherapy within 4 weeks before the commencement of study
• Active uncontrolled infection
• Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (\<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (\<6 months before enrollment)
• Poor compliance
• Pregnant or breastfeeding women, where pregnancy is confirmed by a positive hCG laboratory test.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Chi Mei Medical Hospital: collaborator
• Kaohsiung Medical University: collaborator
• Kaohsiung Veterans General Hospital.: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

MeSH Terms

Interventions

Crizotinib

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Keng-Fu Hsu, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: July 24, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)