Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Ramucirumab

Criteria

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