A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer

Phase 1

Completed

• Conditions: Gastric or Gastroesophageal Cancer
• Interventions: Drug: FPA144

• Registration Number: NCT05913115
• Lead Sponsor: Amgen

Brief Summary

The main objectives of this study are:

* To determine the recommended dose (RD) of FPA144 in participants with gastric or gastroesophageal cancer (hereafter referred to as gastric cancer)

* To evaluate the safety of escalating doses of FPA144 in participants with gastric cancer

* To characterize the pharmacokinetic (PK) profile of single and multiple doses of intravenously administered FPA144 in participants with gastric cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-12
• Primary Completion: 2018-06-19
• Study Completion: 2018-06-19
• Status Verified: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate hematological, liver and kidney function. Measurable or non-measurable disease
• Archival tumor tissue for determination of FGFR2 status

Key

Exclusion Criteria

• Untreated or symptomatic central nervous system (CNS) metastases
• Clinically significant cardiac disease
• Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
• Active infection requiring systemic treatment
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
• Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
• Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
• Known positivity for human epidermal growth factor receptor 2 (HER2)
• Women who are pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FPA144	FPA144	Participants will receive escalating doses of FPA144. On completion of Cycle 1 (Cycles = 28 days in length) participants may participate in an optional Extended Treatment Period based on the Investigator's discretion, which begins on Day 1 of Cycle 2. FPA144 will be administered once every 2 weeks (Q2W) in 4-week cycles until disease progression, or until the patient meets any of the other withdrawal criteria.

Primary Outcome Measures

Name	Time	Method
Clearance (CL) of FPA144	Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Volume of Distribution of FPA144	Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Number of Participants who Experience Grade 3 or Grade 4 Dose-limiting Toxicities (DLTs)	Day 1 to Day 28 of Cycle 1	DLTs are defined as specific adverse events (AEs) or clinically laboratory abnormalities that occur during the DLT observation period (Day 1 to Day 28 of Cycle 1; cycle = 28 days), that the Cohort Review Committee (CRC) assess as related to FPA144. Events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 3: Severe or medically significant but non-immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE; * Grade 4: Life-threatening consequences; urgent intervention indicated
Area Under Serum Concentration-time Curve (AUC) of FPA144	Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Maximum Serum Concentration (Cmax) of FPA144	Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Trough Serum Concentration (Ctrough) of FPA144	Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Terminal Half-life (t1/2) of FPA144	Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

Secondary Outcome Measures

Name	Time	Method
Number of Participants who Experience Treatment-emergent AEs (TEAEs)	Approximately 1 year	TEAEs will be graded using the NCI CTCAE version 4.03. Any clinically significant laboratory abnormalities will also be reported as TEAEs.

Trial Locations

Locations (2)

St Marianna University Hospital; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan