Clinical trial · Interventional
Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca
Phase I/II Study of Abemaciclib + Ramucirumab in Metastatic Esophageal/Gastroesophageal Junction Carcinomas
NCT04921904CI-TRIAL-00102530completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abemaciclib plus Ramucirumab
- description
- Abemaciclib 150mg dose administered orally twice daily every day plus Ramucirumab dose 8mg/kg iv every 2 weeks until evidence of disease
- interventionNames
- Drug: Abemaciclib
- Drug: Ramucirumab
Primary outcomes (1)
- measure
- Safety of Abemaciclib + Ramucirumab
- timeFrame
- 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
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Subjects must meet all eligibility criteria. The key inclusion and exclusion criteria are as follows: Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Squamous cell carcinomas * Mixed histology with small cell component
References
Publications (0)
Data not yet available
No reference posted for this study.