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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Futibatinib

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Paclitaxel

    Drug

    Given IV

  • Ramucirumab

    Biological/Vaccine

    Given IV

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Treatment (futibatinib, paclitaxel, ramucirumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose

Defined as the highest dose that causes dose-limiting toxicities (DLTs) in \< 2 of 6 subjects. Will be estimated using the Bayesian Optimal Interval algorithm based on observed DLTs. The frequency of DLTs at each dose level will be summarized using descriptive statistics, including proportions and confidence intervals.

Time frame
From cycles 1 day 8 (start of Futibatinib) to cycle 2 day 8 (cycle length = 28 days)
2

Recommended phase 2 dose

Time frame
Up to 2 years

Secondary outcomes

1

Incidence of adverse events

Defined as the frequency of adverse events by type, severity (grade), timing, and attribution to \[study drugs, according the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Up to 2 years
2

Objective response rate

Defined as the proportion of treated patients who experience an objective response (confirmed complete response \[CR\] or confirmed partial response \[PR\]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be calculated with corresponding 95% confidence intervals.

Time frame
From treatment initiation until the response has been confirmed, the patient experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation, up to 2 years after completion of study treatment
3

Duration of response (DOR)

Response is defined as confirmed complete response or confirmed partial response per RECIST 1.1; and disease progression is defined as progressive disease per RECIST 1.1. Will be summarized using the Kaplan-Meier method, with estimates of median DOR and corresponding 95% confidence intervals.

Time frame
From the first scan showing CR or PR to disease progression or death, up to 2 years after completion of study treatment
4

Progression free survival (PFS)

PFS will be calculated based on the Kaplan-Meier estimates of PFS. Disease progression is defined as progressive disease per RECIST 1.1, other documented clinical or radiographical progression per physician judgement, or death due to disease.

Time frame
From treatment initiation and the earlier of the day of first documented disease progression or death, up to 2 years after completion of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: