Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca
Phase I/II Study of Abemaciclib + Ramucirumab in Metastatic Esophageal/Gastroesophageal Junction Carcinomas
1 other identifier
interventional
8
1 country
1
Brief Summary
CDK4/6 and Cyclin D1 are significantly expressed in approximately 80% of esophageal and gastroesophageal junction tumors suggesting that CDK4/6 inhibition may be a successful strategy in these chemotherapy and immunotherapy resistant diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2021
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedStudy Start
First participant enrolled
June 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedFebruary 5, 2026
November 1, 2025
3.6 years
June 1, 2021
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To describe the safety profile of Abemaciclib + Ramucirumab as assessed according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
24 months
Secondary Outcomes (4)
To assess objective response rate
24 months
To assess progression free survival
24 months
To assess overall survival
24 months
To determine the rate of stable disease at 3 months post targeted therapy
24 months
Study Arms (1)
Abemaciclib plus Ramucirumab
EXPERIMENTALAbemaciclib 150mg dose administered orally twice daily every day plus Ramucirumab dose 8mg/kg iv every 2 weeks until evidence of disease
Interventions
Eligibility Criteria
You may not qualify if:
- All subjects must have metastatic esophageal or gastroesophageal junction carcinomas (adenocarcinoma only)
- ECOG performance status of 0 or 1
- Tumor tissue must be available for correlative studies - Either a formalin fixed paraffin block or a minimum of ten 5-micron tissue section's (slides) of tumor biopsy sample must be available for biomarker evaluation.
- Patients must have received at least one prior line of standard systemic therapy for recurrent or Stage IV disease, and that patients with HER2 overexpression have received an anti-HER2 drug.
- Squamous cell carcinomas
- Mixed histology with small cell component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor University Medical Center, Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronan Kelly, MD
Charles A Sammons Cancer Center/Texas Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 10, 2021
Study Start
June 11, 2021
Primary Completion
December 31, 2024
Study Completion (Estimated)
June 1, 2026
Last Updated
February 5, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share