Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT02848443
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Trifluridine/tipiracil hydrochloride (S 95005) — DRUG
    Film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, given orally at the dose of 25 or 30 or 35 mg/m2/dose, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
  • Oxaliplatin — DRUG
    Concentrate for solution for infusion containing 5mg/ml of oxaliplatin, administered intravenously at the dose of 65 to 85 mg/m2, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
  • Bevacizumab — DRUG
    Concentrate for solution for infusion containing 25mg/ml of bevacizumab, administered intravenously at the dose of 5 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
  • Nivolumab — DRUG
    Concentrate for solution for infusion containing 10mg/ml of nivolumab, administered intravenously at the dose of 3 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.

Study Details

The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer.

Key Dates

Start date
May 31, 2016
Status verified
Jul 2024
Primary completion
Aug 1, 2019
Completion
Apr 9, 2020

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: S 95005 + oxaliplatin (+/- bevacizumab or nivolumab)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of S95005 when given in combination with oxaliplatin [ Time Frame: up to 4 weeks after the first treatment administration ]

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