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AzTrials

Recurrent Metastatic Nasopharyngeal CarcinomaPhase 3NCT05717764

Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Capecitabine Versus Capecitabine Monotherapy in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma Who Failed Platinum-containing Treatment

A Phase 3 study testing Mitoxantrone hydrochloride liposome injection and Capecitabine in people with Recurrent Metastatic Nasopharyngeal Carcinoma, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mitoxantrone hydrochloride liposome injection and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
No sites listed yet
Study dates
Feb 2023to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 0-1.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Other active malignant tumors within 2 years prior to the first study drug administration.
  • Abnormal heart function, including:
  • Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block, second-degree or third-degree atrioventricular block; Severe, uncontrolled arrhythmias requiring medication; History of chronic congestive heart failure with NYHA ≥ grade 3; Cardiac ejection fraction less than 50% or lower than the lower limit of the laboratory test range within 6 months prior to screening; CTCAE version 5.0 ≥ grade 3 valvular heart disease; Uncontrolled hypertension (defined as measuring systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg when medically controlled); Myocardial infarction, unstable angina, history of severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to screening.
  • Prior treatment with doxorubicin or other anthracyclines and the cumulative doxorubicin doses greater than 350 mg/m^2 (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone).
  • Pregnant or lactating women.
  • Have any serious and/or uncontrollable medical conditions that, as determined by the investigator, may affect the patient's participation in the study.
  • Have severe gastrointestinal disorders that affect the ingestion, transport, or absorption of medications.
  • Other situations that the investigator determines to be inappropriate for participation.

About this study

Official title: 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

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.

Read the 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.

Being tested
Mitoxantrone hydrochloride liposome injection, Capecitabine
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitoxantrone hydrochloride liposome injectionDrug

    Mitoxantrone hydrochloride liposome injection will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.

  • CapecitabineDrug

    Capecitabine will be administered orally in a 3-week treatment cycle, twice a day from day 1 to day 14 of each cycle.

Study groups in NCT05717764
Study groupRoleWhat they receive
Experimental groupExperimentalPatients will receive mitoxantrone hydrochloride liposome injection combined with capecitabine therapy
Receives: Drug: Mitoxantrone hydrochloride liposome injection; Drug: Capecitabine
Control groupActive comparatorPatients will receive capecitabine monotherapy.
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) assessed by the independent review committee (IRC)

    Progression-Free Survival PFS is defined as the time from randomization to progression or death

    Measured: Throughout the study period, up to approximately 2 years

  2. Overall survival (OS)

    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.

    Measured: Throughout the study period, up to approximately 2 years

Secondary outcomes (6)

  1. Objective response rate (ORR) assessed by the investigator and IRC

    Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment

    Measured: Throughout the study period, up to approximately 2 years

  2. Disease control rate (DCR) assessed by the investigator and IRC

    Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents

    Measured: Throughout the study period, up to approximately 2 years

  3. Duration of Response (DOR) assessed by the investigator and IRC

    Duration of Response (DOR) is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death

    Measured: Throughout the study period, up to approximately 2 years

  4. Progression-free survival (PFS) assessed by the investigator

    Progression-Free Survival PFS is defined as the time from randomization to progression or death

    Measured: Throughout the study period, up to approximately 2 years

  5. Frequency and severity of AE (NCI CTCAE 5.0)

    Measured: Throughout the study period, up to approximately 2 years

  6. Blood concentrations of total and free mitoxantrone

    Measured: At the end of Cycle 4 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study startFeb 2023 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05717764
Sponsor's protocol ID
HE071-031
Status last verified
Dec 2022
First submitted
11 Jan 2023
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mitoxantrone hydrochloride liposome injection and Capecitabine in people with Recurrent Metastatic Nasopharyngeal Carcinoma, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by the independent review committee (IRC) (time frame: Throughout the study period, up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05717764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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