ONO-4538 Phase II Rollover Study (ONO-4538-98)

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT04566380
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pan-tumor

Eligibility Criteria

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

Interventions

  • ONO-4538 — DRUG
    IV infusion over 30 minutes
  • oxaliplatin — DRUG
    IV infusion over 2 hours
  • S-1 — DRUG
    Administered orally twice daily
  • capecitabine — DRUG
    Administered orally twice daily
  • bevacizumab — DRUG
    IV infusion over 30 minutes
  • temozolomide — DRUG
    Administered orally once daily for 5 days every 28 days

Study Details

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

Key Dates

First listed
Sep 28, 2020
Start date
Sep 10, 2020
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
59 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-4538 Monotherapy cohort
    480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice
  • Experimental: Combination therapy cohort
    ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin \[SOX\] therapy , Capecitabine + Oxaliplatin \[CapeOX\] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.

Primary Outcome Measure

Incidence of Adverse Events (Aes) [ Time Frame: From Day 1 up to 28 days after the end of the treatment phase ]

Central Contacts