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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Guizhou Cancer Hospital
Guiyang, Guizhou, China
adverse events (AEs)
The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments, ultrasonic cardiograms (UCGs) and electrocardiographs (ECGs).
Time frame: from the initiation of the first dose to 28 days after the last dose,assessed up to 36 months
overall response rate (ORR)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)
duration of response (DoR)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
duration of complete response (DCR)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
progression-free survival (PFS)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
overall survival (OS)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)
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Harbin Medical University Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China