Recurrent Head and Neck CancerPhase 1NCT04902027
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) in people with Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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 recurrent/metastatic Head and Neck Cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
- What is being tested?
- Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 23 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- . Age ≥18, female or male;
- Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
- Fail to respond to or progressed on at least one line of the standard therapy;
- At least one measurable lesion according to RECIST v1.1;
- ECOG performance status of 0 to 1;
- AEs from the previous treatment have resolved to ≤ Grade 1 based on
Who cannot join
- History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- History of allotransplantation;
- Life expectancy < 3 months
- Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
- Serious infection or interstitial pneumonia within 1 week prior to the first dose administration;
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- Use of other anticancer treatment within 4 weeks prior to the first dose administration;
- Enrolled in any other clinical trials within 4 weeks prior to the first dose administration;
- Major surgery within 3 months prior to the first dose administration, or have a surgical schedule during the study period;
- Thrombosis or thromboembolism within 6 months prior to screening;
- History of, or known additional malignant tumor within 3 years, except for tumors have been cured and have not recurred, and carcinoma in situ;
- Impaired cardiac function or serious cardiac disease
- Previous treatment with adriamycin or other anthracyclines, and the total cumulative dose of prior adriamycin or equivalent is >350 mg/m2
- Pregnant or lactating female;
- Serious and/or uncontrolled systemic diseases;
- Not suitable for this study as decided by the investigator due to other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection 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
Read the 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 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.
- Being tested
- Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)Drug
All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection | Experimental | Subjects with Rrecurrent/metastatic Head and Neck Cancers will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles Receives: Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the initiation of the first dose to 28 days after the last dose
Secondary outcomes (4)
(best total response) (BOR)
To investigate the preliminary antitumor efficacy
Measured: 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
Measured: 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
Measured: 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
Measured: from date of enrollment until date of first death from any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jul 2021
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiming Li, MD, Study chair, Cancer Prevention Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902027
- Sponsor's protocol ID
- HE071-CSP-016
- Status last verified
- Feb 2024
- First submitted
- 18 Mar 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Recurrent/Metastatic Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT04902027
- Acronym / sponsor ID
- HE071-CSP-016
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection | Experimental | Drug: Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)Subjects with Rrecurrent/metastatic Head and Neck Cancers will receive 20 mg/m2 Mitoxantrone Hydrochloride Liposome every 21 days (a cycle) for a maximum of 8 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- . Age ≥18, female or male;
- Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
- Fail to respond to or progressed on at least one line of the standard therapy;
- At least one measurable lesion according to RECIST v1.1;
Key exclusion criteria (16 listed)
- History of allergy to mitoxantrone hydrochloride or any excipients of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- History of allotransplantation;
- Life expectancy < 3 months
- Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Mitoxantrone Hydrochloride Liposome Injection |
Primary outcome
adverse events (AEs),,graded according to the NCI CTCAE version 5.0
Time frame: from the initiation of the first dose to 28 days after the last dose
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
4 secondary outcomes
(best total response) (BOR)
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)
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)
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)
Time frame: from date of enrollment until date of first death from any cause, assessed up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiming Li, MD study chair
Cancer Prevention Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome, intravenous injection (IV) in people with Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adverse events (AEs),,graded according to the NCI CTCAE version 5.0 (time frame: from the initiation of the first dose to 28 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.