This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with recurrent/metastatic Head and Neck Cancers
This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with recurrent/metastatic head and neck cancers. 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 withdrawa 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
45
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
adverse events (AEs),,graded according to the NCI CTCAE version 5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: from the initiation of the first dose to 28 days after the last dose
(best total response) (BOR)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to the final documentation of response of the last subject ( at least 6 weeks between follow-up and enrolment
duration of response (DoR)
To investigate the preliminary antitumor efficacy
Time frame: From the enrollment to CR, PR, PD, death, lost to follow-up, withdrawal, or study end, assessed up to 2 years
progression-free survival (PFS)
To investigate the preliminary antitumor efficacy
Time frame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
overall survival (OS)
To investigate the preliminary antitumor efficacy
Time frame: from date of enrollment until date of first death from any cause, assessed up to 2 years
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