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Advanced Pancreatic CancerPhase 2NCT05100329

A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome injection in people with Advanced Pancreatic Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Mitoxantrone Hydrochloride Liposome injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
Nov 2021to May 2024
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients fully understand and voluntarily participate in this study and sign informed consent;
  • Aged 18-75 years (inclusive), without gender limitation;
  • Histologically or cytologically confirmed advanced pancreatic tumors;
  • Patients with locally progressive or metastatic pancreatic cancer who have disease progression after receiving first line or above standard treatment.
  • At least one measurable lesion according to RECIST v1.1 at baseline;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
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  • Adequate organ function defined as (No G-CSF treatment or blood transfusion within 2 weeks prior to the first dose):
  • Absolute neutrophil count (ANC) ≥1.5*10^9/L;
  • Hemoglobin ≥ 90 g/L;
  • Platelet count ≥ 100 * 10^9/L;
  • Creatinine ≤1.5 * upper limit of normal (ULN);
  • Total bilirubin ≤2 * ULN;
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3 * ULN (≤ 5 * ULN in patients with hepatic metastasis);
  • Coagulation: prothrombin time (PT) or International Normalization Ratio (INR) ≤1.5 * ULN.
  • Female patients must have a urine or blood HCG negative test before enrolment (except for menopause and hysterectomy); Patients and their partners must agree to use effective contraceptive measures during the study until 6 months after the end of the last dose.
  • Good compliance and willingness to cooperate with follow-up visits.

Who cannot join

  • History of severe allergy to mitoxantrone hydrochloride or any excipients of the study drug;
  • History of other malignant tumor in previous 3 years, not including cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma.
  • Cerebral or meningeal metastases;
  • Patients with chronic hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU/mL), chronic hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
  • Life expectancy < 3 months;
  • Previous treatment with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) >350 mg/m^2;
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  • AEs from the previous treatment have not resolved to ≤ Grade 1 based on CTCAE (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation);
  • Patients with the following cardiac function defects:
  • Long QTc syndrome or QTc interval > 480 ms;
  • Complete left bundle branch block, II-III degree atrioventricular block;
  • Severe, uncontrolled arrhythmias requiring pharmacological treatment;
  • History of chronic congestive heart failure, NYHA ≥ grade 3;
  • Cardiac ejection fraction < 50% within 6 months prior to screening;
  • Heart valve disease with CTCAE ≥ grade 3;
  • History of myocardial infarction, unstable angina, severe ventricular arrhythmias, severe pericardial disease, or ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to screening;
  • Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);
  • Malignant serous cavity effusion (e.g. pleural effusion, pericardial effusion, ascites);
  • Active bacterial, fungal or viral infections requiring intravenous infusion treatment within 1 week prior to the first dose;
  • Any anticancer treatment within 4 weeks prior to the first dose (e.g., radiotherapy, targeted therapy, immunotherapy, endocrine therapy, etc.); Traditional Chinese medicine or proprietary Chinese medicine with an approved oncology indication within 2 weeks prior to the first dose;
  • Enrolled in any other clinical trials within 4 weeks prior to the first dose;
  • Patients underwent major surgery within 12 weeks prior to the first dose, or have a surgical schedule during the study period;
  • Having a schedule of other anti-cancer treatment during the study period.
  • Deep vein thrombosis or arterial embolism within the previous 6 months, including but not limited to superior/inferior vena cava thrombosis, lower limb deep vein thrombosis, pulmonary embolism;
  • Lactating female;
  • Serious and/or uncontrolled medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, neurological disorders, etc.);
  • Not suitable for this study as decided by the investigator due to other reasons.

Trial locations and contacts

No sites are listed yet.

Xuefang Xia contact

+86-010-63932012

xiaxuefang@mail.ecspc.com

About this study

Official title: Safety, Tolerability, and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer: A Multicenter, Open-label, Phase Ⅱ Study

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced pancreatic cancer.

Read the detailed description

This is a multicenter, open-label, phase Ⅱ study aimed to evaluate the safety, tolerability, and efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced pancreatic cancer. Patients enrolled in this study will receive mitoxantrone hydrochloride liposome injection every 3 weeks (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles).

Being tested
Mitoxantrone Hydrochloride Liposome injection

What participants receive

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

  • Mitoxantrone Hydrochloride Liposome injectionDrug

    20 mg/m^2, IV, on day 1 of every 3 weeks (q3w, a cycle)

Study groups in NCT05100329
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome InjectionExperimentalPatients will receive mitoxantrone hydrochloride liposome injection every 3 weeks (q3w, a cycle).
Receives: Drug: Mitoxantrone Hydrochloride Liposome injection

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Measured: Up to approximately 3 years

Secondary outcomes (5)

  1. Overall survival (OS)

    OS is defined as the time from the date of first dose until the date of death from any cause.

    Measured: Up to approximately 3 years

  2. Progression-free survival (PFS)

    PFS is defined as the time from the date of first dose until the date of first documented progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first

    Measured: Up to approximately 3 years

  3. Disease control rate (DCR)

    DCR is defined as the proportion of patients who have a response of CR/PR or stable disease (SD) as per RECIST 1.1.

    Measured: Up to approximately 3 years

  4. Duration of response (DoR)

    DoR is defined as the time from the first assessment of CR or PR until the date of first occurrence of progressive disease （PD） as per RECIST 1.1 or death from any cause, whichever occurs first.

    Measured: Up to approximately 3 years

  5. Treatment-emergent adverse events (TEAEs)

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted29 Oct 2021
  2. Study startNov 2021 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionMay 2024 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100329
Sponsor's protocol ID
HE071-CSP-026
Status last verified
Jun 2021
First submitted
19 Oct 2021
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome injection in people with Advanced Pancreatic Cancer, run by CSPC ZhongQi Pharmaceutical Technology 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 16 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Xuefang Xia (+86-010-63932012, xiaxuefang@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 3 years). 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 NCT05100329.

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 29 Oct 2021.

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