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Study Complete
Sponsor ID
FPA144-002

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

Sponsor ID
FPA144-002
Clinicaltrials.gov ID
NCT05913115
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
6
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants who Experience Grade 3 or Grade 4 Dose-limiting Toxicities (DLTs)

Timeframe: Day 1 to Day 28 of Cycle 1

Area Under Serum Concentration-time Curve (AUC) of FPA144

Timeframe: 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

Timeframe: 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

Timeframe: 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

Clearance (CL) of FPA144

Timeframe: 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

Timeframe: 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

Timeframe: 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

Number of Participants who Experience Treatment-emergent AEs (TEAEs)

Timeframe: Approximately 1 year

Locations

Location
Status
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Location
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan, 216-8511
Status
Completed
Location
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Status
Completed
Study Info
Age
18 - NA
Condition
  • Gastrointestinal Cancer
    • Sex
    All
    Trial Dates
    Jun 2017 - Jun 2018
    Inclusion and Exclusion Criteria
    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
    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