Trials / Terminated
TerminatedNCT04718376
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer
A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer.
Detailed description
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with Platinum-Resistant or Platinum-Refractory Relapsed Ovarian Cancer. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles). Delays in drug administration is allowed from the cycle 2, however, the delays should be no more than 3 weeks. Dose adjustments after the cycle 2 is permitted, and the minimum dose is 12mg/m2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) | All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w). |
Timeline
- Start date
- 2021-01-12
- Primary completion
- 2023-05-22
- Completion
- 2023-05-22
- First posted
- 2021-01-22
- Last updated
- 2024-03-07
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04718376. Inclusion in this directory is not an endorsement.