Gastric or Gastroesophageal Cancer
Conditions
Keywords
FPA144
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
Interventions
DRUGFPA144
FPA144 will be administered intravenously Q2W.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed