Health Trials

Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

ConditionsClinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Locally Advanced Esophageal AdenocarcinomaLocally Advanced Gastric AdenocarcinomaLocally Advanced Gastroesophageal Junction AdenocarcinomaMetastatic Esophageal AdenocarcinomaMetastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaUnresectable Esophageal AdenocarcinomaUnresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

Eligibility criteria

Qualifiers

Patients must have histologically or cytologically confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma that is microsatellite stable and HER2 negative. (American Joint Committee on Cancer [AJCC] staging criteria; https://pmc.ncbi.nlm.nih.gov/articles/PMC5387145/)

Note: Histological or cytological test reports from external laboratories outside of Northwestern University (NU) will also be accepted

Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Note: Patients must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 90 days prior to registration for participants with measurable disease

Disqualifiers

Patients with adenosquamous or mixed histology disease

Patients who have received/are receiving other investigational agents, or anticancer/antineoplastic therapy including chemotherapy, immunotherapy, biological response modifiers, anti-neoplastic endocrine therapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of cycle 1

Patients who have previously received a FGFR inhibitor.

Note: Agents that are multi-kinase inhibitors are allowed

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Futibatinib
  • Magnetic Resonance Imaging
  • Paclitaxel
  • Ramucirumab

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov