A Randomized, Open-label, Positive-controlled, Multicenter Phase Ш Study Comparing Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Therapy
Overview
- Phase
- Phase 3
- Intervention
- Mitoxantrone hydrochloride liposome injection
- Conditions
- Recurrent Metastatic Nasopharyngeal Carcinoma
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Enrollment
- 500
- Primary Endpoint
- Progression-free survival (PFS) assessed by the independent review committee (IRC)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a randomized, open-label, positive-controlled, multicenter Phase Ш study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in patients with recurrent metastatic nasopharyngeal carcinoma.
Detailed Description
Five hundred patients with recurrent metastatic nasopharyngeal carcinoma will be randomly assigned to the experimental group or the control group. The experimental group will receive mitoxantrone hydrochloride liposome injection combined with capecitabine, and the control group will receive capecitabine alone. All patients will be treated until disease progression as determined by the investigator based on RECIST 1.1 criteria, intolerable toxicity, subject withdrawal of informed consent, initiation of new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing to participate in the study and sign the informed consent form (ICF).
- •Age ≥ 18 years.
- •Nasopharyngeal carcinoma confirmed by histopathology.
- •Recurrent metastatic nasopharyngeal carcinoma that has previously failed treatment with first-line platinum-containing standard regimens and/or second-line standard regimens.
- •At least one evaluable lesion at baseline according to RECIST 1.1 criteria; The area should not have received previous radiotherapy, or there is evidence that the lesion has made definite progress after radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) score 0-
- •Toxic reaction caused by any previous antitumor treatment has recovered to grade 1 or below (except for alopecia, pigmentation, or other toxicities deemed by the investigator to pose no safety risk to the patient).
- •Adequate main organ function.
- •Female patients must have a negative blood HCG test (except for menopause and hysterectomy), Female patients of childbearing age and their partners must use effective contraception (For example: combination hormones \[containing estrogen and progesterone\] to suppress ovulation, progestogen contraception to suppress ovulation, intrauterine device, intrauterine hormone release system, bilateral tubal ligation, vasectomy, avoidance of sexual activity, etc) during the trial and within 6 months of the end of the last dose.
- •Male patients and their partners agree to use one of the contraceptive measures described in Article 9.
Exclusion Criteria
- •Severe allergy to mitoxantrone or liposome; Previous severe, unexpected reactions to fluorouracil or known allergy to fluorouracil or to any excipients of capecitabine.
- •Previous treatment regimens containing capecitabine for recurrent or metastatic nasopharyngeal carcinoma; Patients with locally advanced nasopharyngeal carcinoma have previously experienced disease recurrence or metastasis during or within 6 months of use of capecitabine.
- •Patients with brain or meningeal metastasis.
- •Expected lifetime \< 3 months.
- •Patients with active hepatitis B, hepatitis C or HIV.
- •Active bacterial infection, fungal infection, viral infection, or interstitial pneumonia requiring systemic therapy within 1 week prior to the first administration of the study drug.
- •Antitumor therapy such as chemotherapy, small-molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to initial administration of the study drug; Received Chinese patent drugs with antitumor activity within 14 days prior to administration.
- •Have received other investigational drugs within 4 weeks prior to initial administration.
- •Patients had major surgery within 3 months prior to initial dosing or plan to have major surgery during the study period.
- •Severe embolic events, such as cerebrovascular accidents (including transient ischemic attacks) and pulmonary embolism, occurred within 6 months prior to screening.
Arms & Interventions
Experimental group
Patients will receive mitoxantrone hydrochloride liposome injection combined with capecitabine therapy
Intervention: Mitoxantrone hydrochloride liposome injection
Experimental group
Patients will receive mitoxantrone hydrochloride liposome injection combined with capecitabine therapy
Intervention: Capecitabine
Control group
Patients will receive capecitabine monotherapy.
Intervention: Capecitabine
Outcomes
Primary Outcomes
Progression-free survival (PFS) assessed by the independent review committee (IRC)
Time Frame: Throughout the study period, up to approximately 2 years
Progression-Free Survival PFS is defined as the time from randomization to progression or death
Overall survival (OS)
Time Frame: Throughout the study period, up to approximately 2 years
Overall survival (OS) is defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Secondary Outcomes
- Objective response rate (ORR) assessed by the investigator and IRC(Throughout the study period, up to approximately 2 years)
- Progression-free survival (PFS) assessed by the investigator(Throughout the study period, up to approximately 2 years)
- Blood concentrations of total and free mitoxantrone(At the end of Cycle 4 (each cycle is 28 days))
- Duration of Response (DOR) assessed by the investigator and IRC(Throughout the study period, up to approximately 2 years)
- Disease control rate (DCR) assessed by the investigator and IRC(Throughout the study period, up to approximately 2 years)
- Frequency and severity of AE (NCI CTCAE 5.0)(Throughout the study period, up to approximately 2 years)