Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca

NCT04921904 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 020-055
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 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.

Conditions

Metastatic Esophageal Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Safety of Abemaciclib + Ramucirumab

  The safety profile was assessed by counting the number of patients who experienced adverse events (AEs) and serious adverse events (SAEs) of Grade 3 or higher while on study using CTCAE v4.0 criteria.

  From date of study enrollment, through treatment, and during follow-up until 100-days after the last dose of study medication or death, from any cause, whichever occurred first, assessed up to 24 months

Secondary Outcomes (4)

• Objective Response Rate

  From date of study enrollment until the date of death, from any cause, assessed up to 24 months

• Progression Free Survival

  From date of study enrollment until the date of first radiographic tumor progression or death from any cause, whichever came first, assessed up to 24 months.

• Overall Survival

  From date of study enrollment until the date of death, from any cause, assessed up to 24 months

• Rate of Stable Disease

  At 3 months after targeted therapy initiation

Study Arms (1)

Abemaciclib plus Ramucirumab

EXPERIMENTAL

Abemaciclib 150mg dose administered orally twice daily every day plus Ramucirumab dose 8mg/kg iv every 2 weeks until evidence of disease

Drug: Abemaciclib; Drug: Ramucirumab

Interventions

Abemaciclib DRUG

150mg dose administered orally twice daily every day

Abemaciclib plus Ramucirumab

Ramucirumab DRUG

8mg/kg iv every 2 weeks until evidence of disease

Abemaciclib plus Ramucirumab

Eligibility Criteria

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

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center, Charles A Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

abemaciclib; Ramucirumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Page Blas
• Organization: Baylor Scott & White Research Institute

page.blas@bswhealth.org

2148205424

Study Officials

• Ronan Kelly, MD

  Charles A Sammons Cancer Center/Texas Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: August 14, 2025
• Last Updated: September 14, 2026
• Results First Posted: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)