Study of Irinotecan Liposome Injection in Patients With Advanced Breast Cance

Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Study ID
NCT04728035
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is an open-label, single-arm, phase I study of irinotecan liposome injection in patients with advanced breast cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced breast cancer.

Key Dates

Start date
May 31, 2021
Status verified
Dec 2020
Primary completion
Jun 5, 2023
Completion
Jun 5, 2024

Study Design

Enrollment
119 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation (part 1)
    Patients will receive irinotecan liposome injection (CSPC) at the initial starting dose until progression or unacceptable toxicity.
  • Experimental: Dose expansion (part 2)
    Once the appropriate dose has been established in Part 1, patients will be enrolled into two expansion cohorts according to the sub-type of breast cancer.

Primary Outcome Measure

Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to six months after the last patient's first administration ]

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