Metastatic Esophageal AdenocarcinomaPhase 1/2NCT04921904
Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca
A Phase 1/2 study testing Abemaciclib and Ramucirumab in people with Metastatic Esophageal Adenocarcinoma and Metastatic Gastroesophageal Junction Adenocarcinoma, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Esophageal Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Abemaciclib and Ramucirumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 14 Aug 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Squamous cell carcinomas
- Mixed histology with small cell component
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center, Charles A Sammons Cancer Center
Dallas, Texas, 75246
About this study
Official title: Phase I/II Study of Abemaciclib + Ramucirumab in Metastatic Esophageal/Gastroesophageal Junction Carcinomas
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.
Read the detailed description
This is a multicenter, open label, phase I/II safety study that will enroll 30 subjects with metastatic esophageal and gastroesophageal junction adenocarcinomas post first line systemic chemotherapy. Subjects will be treated with oral Abemaciclib 150 mg PO daily bid given with ramucirumab 8mg/kg every 2 weeks iv until evidence of disease progression or unacceptable toxicities.
A total of 30 subjects will be enrolled. The primary goal is to describe the safety profile of Abemaciclib in combination with Ramucirumab among all enrolled subjects.
If grade 3 or higher treatment-related adverse events occur in 20 subjects, the upper bound of 95% Wilson confidence interval for the adverse event rate would be below 81% (16.7% - 47.9%).
The safety analysis will be performed in all treated subjects. Adverse event data will be listed individually and graded according to the National Cancer Institute Common Terminology Criteria, version 4.03.
Summary statistics will include counts and proportions as well as rates with 95% confidence intervals. Toxicities will be reported as a tabulated table by type and grade.
Objective response rate is defined as the percentage of subjects who achieve an objective response by RECIST1.1 criteria (i.e. Complete response or Partial Response) to Abemaciclib in combination with Ramucirumab. We will estimate the objective response rate, along with the Wilson 95% confidence interval, for the population of subjects.
Overall survival will be defined as the time from study enrollment to death. This will be summarized using a Kaplan-Meier curve.
The proportion of subjects with grade 4 or higher treatment-related adverse events will be monitored continuously throughout the trial using a Bayesian stopping guideline. A Beta (1, 19) prior, representing a toxicity rate of 5%, slightly lower than the expected rate of 6%, was used in the development of our guidelines. The therapy will be re-evaluated if the posterior probability that the toxicity rate exceeds 10% is greater than 75%. Table 3 summarizes the stopping boundaries starting with the initial cohort of 3 subjects through the maximum sample size of 30 subjects.
The probability of triggering the stopping guidelines was assessed for a range of possible toxicity rates using simulations with 5000 replicates. The probability of stopping to re-evaluate was 1% if the true proportion with an unacceptable toxicity was 5%. In comparison, the probability of stopping early was 99.6% if the true proportion with an unacceptable toxicity was 40%
- Being tested
- Abemaciclib, Ramucirumab
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
150mg dose administered orally twice daily every day
RamucirumabDrug
8mg/kg iv every 2 weeks until evidence of disease
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Abemaciclib; Drug: Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Objective response rate is defined as the number of subjects who achieve an objective response by RECIST1.1 criteria (i.e., Complete Response or Partial Response) to Abemaciclib in combination with Ramucirumab.
Measured: From date of study enrollment until the date of death, from any cause, assessed up to 24 months
Progression Free Survival
The duration of progression-free survival is measured from the time of randomization to radiographic tumor progression or death.
Measured: 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
Overall survival will be defined as the time from study enrollment to death.
Measured: From date of study enrollment until the date of death, from any cause, assessed up to 24 months
Rate of Stable Disease
Rate of stable disease is defined as having a reading of stable disease or better per RECIST 1.1 criteria.
Measured: At 3 months after targeted therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start11 Jun 2021
- Primary completion31 Dec 2024
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronan Kelly, MD, Principal investigator, Charles A Sammons Cancer Center/Texas Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921904
- Sponsor's protocol ID
- 020-055
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2021
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No