Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor
Gilead Sciences
Study ID
NCT02862535
Phase
PHASE1
Status
Terminated

Conditions

  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Andecaliximab — DRUG
    Administered via intravenous (IV) infusion (approximately 30 minutes)
  • S-1 — DRUG
    Administered orally
  • Cisplatin — DRUG
    Administered via IV infusion on Day 8 of every 5 weeks
  • Oxaliplatin — DRUG
    Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle
  • Nivolumab — DRUG
    Administered via IV infusion (approximately 60 minutes) every 2 weeks

Study Details

The primary objective of this study is to characterize the safety and tolerability of andecaliximab as monotherapy and in combination with anti-cancer agents in Japanese participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal junction (GEJ) adenocarcinoma.

Key Dates

Start date
Sep 20, 2016
Status verified
Nov 2020
Primary completion
Oct 25, 2019
Completion
Oct 25, 2019

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: ADX
    Participants will receive andecaliximab (ADX) 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
  • Experimental: Cohort 2: ADX + S-1 + Cisplatin
    Participants will receive ADX 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with S-1 orally twice daily plus cisplatin chemotherapy (dosage and regimen will be based on participant condition, investigator discretion, institutional practice, and/or the in-country label) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
  • Experimental: Cohort 3: ADX + S-1 + Oxaliplatin
    Participants will receive ADX 1200 mg every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin 100 mg/m\^2) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.
  • Experimental: Cohort 4: ADX + Nivolumab
    Participants will receive ADX 800 mg every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Primary Outcome Measure

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab) ]

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