Futibatinib + Paclitaxel + Ramucirumab for Stomach Cancer

Not yet recruiting at 1 trial location

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Northwestern University

Must not be taking: FGFR inhibitors

Disqualifiers: Cardiac disease, GI bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Chengwei Peng, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults (18+) with locally advanced or inoperable gastric, gastroesophageal junction, or esophageal adenocarcinoma that is HER2 negative and microsatellite stable. Participants must have measurable disease, good physical function, and no more than one prior treatment for metastatic cancer.

Inclusion Criteria

Aspartate aminotransferase (AST) ≤ 3 x institutional ULN or ≤ 5 x ULN if liver metastases present

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

Alanine aminotransferase (ALT) ≤ 3 x institutional ULN or ≤ 5 x ULN if liver metastases present

Exclusion Criteria

Pregnant or nursing patients

Patients with uncontrolled intercurrent illness including uncontrolled hypertension, active infection requiring systemic treatment, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, psychiatric illness/social situations limiting compliance, or other conditions compromising safety or study endpoints

I have been treated with an FGFR inhibitor before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive ramucirumab IV on days 1 and 15, paclitaxel IV on days 1, 8, and 15, and futibatinib PO daily. Cycles repeat every 28 days.

28 days per cycle

Multiple visits per cycle for IV administration

Dose Escalation

Determination of the maximum tolerated dose of futibatinib in combination with paclitaxel and ramucirumab.

Up to 2 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Every 3 months for 2 years

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Futibatinib
• Paclitaxel
• Ramucirumab

Trial Overview

The study tests the safety and best dose of combining futibatinib with paclitaxel and ramucirumab in patients whose stomach or esophagus cancer cannot be removed by surgery. All participants receive these three drugs together to see how well they work as a team.

How Is the Trial Designed?

Group I: Treatment (futibatinib, paclitaxel, ramucirumab) Experimental Treatment 6 Interventions

Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle, and futibatinib PO QD on days 8-28 of cycle 1 and days 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI, and optional blood and urine sample collection throughout the study.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+