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CDK4/6 Inhibitor

Abemaciclib + Ramucirumab for Esophageal Cancer

Phase 1 & 2
Waitlist Available
Led By Ronan Kelly, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor tissue must be available for correlative studies - Either a formalin fixed paraffin block or a minimum of ten 5-micron tissue sections of tumor biopsy sample must be available for biomarker evaluation
All subjects must have metastatic esophageal or gastroesophageal junction carcinomas (adenocarcinoma only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial suggests that CDK4/6 inhibitors could be a successful treatment for esophageal and gastroesophageal junction tumors, which are often resistant to chemotherapy and immunotherapy.

Who is the study for?
This trial is for adults with metastatic esophageal or gastroesophageal junction cancers (adenocarcinoma only) who have tried at least one standard treatment. They must be relatively fit (ECOG status of 0 or 1) and have tumor samples available for study. It's not open to those with squamous cell carcinomas or mixed histology including small cell components.Check my eligibility
What is being tested?
The trial tests Abemaciclib combined with Ramucirumab in patients whose tumors express CDK4/6 and Cyclin D1, which are common in these cancer types. The goal is to see if this combination can overcome resistance to chemotherapy and immunotherapy.See study design
What are the potential side effects?
Potential side effects may include diarrhea, fatigue, low blood counts leading to increased infection risk, high blood pressure due to Ramucirumab, and possible liver enzyme changes from Abemaciclib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my tumor for study.
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My cancer is in the esophagus or where the stomach meets the esophagus, and it's an adenocarcinoma.
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I've had treatment for advanced cancer and if HER2 positive, received an anti-HER2 drug.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To describe the safety profile of Abemaciclib + Ramucirumab as assessed according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Secondary outcome measures
To assess objective response rate
To assess overall survival
To assess progression free survival
+1 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abemaciclib plus RamucirumabExperimental Treatment2 Interventions
Abemaciclib 150mg dose administered orally twice daily every day plus Ramucirumab dose 8mg/kg iv every 2 weeks until evidence of disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Ramucirumab
FDA approved

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
201 Previous Clinical Trials
203,250 Total Patients Enrolled
Ronan Kelly, MDPrincipal InvestigatorCharles A Sammons Cancer Center/Texas Oncology
1 Previous Clinical Trials
100,000 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04921904 — Phase 1 & 2
Esophageal Cancer Research Study Groups: Abemaciclib plus Ramucirumab
Esophageal Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04921904 — Phase 1 & 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04921904 — Phase 1 & 2
~7 spots leftby Jun 2025
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