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Advanced Breast CancerPhase 1NCT04728035

Study of Irinotecan Liposome Injection in Patients With Advanced Breast Cance

A Phase 1 study testing Irinotecan Liposome Injection in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an open-label, single-arm, phase I study of irinotecan liposome injection in patients with advanced breast cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Irinotecan Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteChina
Study dates
31 May 2021to 5 Jun 2024
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients 1.Female aged between 18 and 75 years.
  • 2.Histologically or cytologically confirmed breast cancer.
  • 3.At least one measurable lesion according to RECIST 1.1.
  • 4.The time interval between the end of the last anti-tumor treatment and the first administration of irinotecan liposome injection is restricted as follows:
  • More than 6 weeks for nitrosoureas (such as carmustine, lomustine, etc.) or mitomycin C.
  • More than 3 weeks for cytotoxic chemotherapeutics, immunotherapy such as PD-1/PD-L1 and biotherapy.
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  • More than 2 weeks (five half-lives, whichever is longer) for oral fluorouracil, oral small molecule targeted drugs, and endocrine therapy.
  • More than 2 weeks for Radiotherapy. (5) More than 2 Weeks for traditional Chinese medicine with anti-tumor indications.
  • 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • 6.Life expectancy >3 months.
  • 7.Patient should not receive blood transfusion or supportive care (eg. EPO, G-CSF or others) within 14 days before the initiate dose, and laboratory test should meet the following criteria: neutrophile count ≥1.5×10^9/L platelet count ≥100×10^9/L hemoglobin ≥90 g/L or ≥5.6 mmol/L serum creatinine ≤1.5×ULN and creatinine clearance rate ≥50 mL/min total bilirubin ≤1×ULN AST and ALT ≤2.5×ULN
  • 8.Patient with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the trial completion and have a negative serum pregnancy test within 7 days before enrollment.
  • 9.Ability to understand and the willingness to sign a written informed consent.
  • Additional criteria for dose escalation and cohort 1 in dose expansion
  • 1.Meet the molecular classification criteria for triple-negative breast cancer.
  • 2.Patients with locally recurrent or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer and had failed to prior chemotherapy due to progression or intolerable toxicity:
  • (1)Early neoadjuvant or adjuvant chemotherapy for localized disease that progresses to unresectable locally advanced or metastatic disease within 12 months after completion is one of the permitted previous chemotherapy regimens.
  • (2)PARP inhibitor for patients with germline BRCA1/BRCA2 mutations who have been treated with approved PARP inhibitors, is one of the permitted prior chemotherapy regimens.
  • 3.Previous treatment with taxanes and anthracyclines was required regardless of the stage of disease (neoadjuvant, adjuvant or palliative). Those who have contraindications or intolerance to a certain drug above should receive at least one cycle of treatment with this drug, and can be exempted from the requirements for the use of this drug.
  • Additional criteria for cohort 2 in dose expansion
  • 1.HER2 negative breast cancer defined as 0 - 1+ by immunohistochemistry or FISH negative result.
  • 2.Evidence of new and/or progressive brain metastases following previous radiotherapy (WBRT and/or SRS and/or gamma knife) and/or surgery.
  • 3.At least one measurable brain lesion (≥10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging).

Who cannot join

  • Patients who have received any investigational drug within 4 weeks of the first dose of the study drug.
  • Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks prior to the first dose of the study drug, or have a schedule for major surgery during the trial.
  • Patients who have concomitant use of strong CYP3A4 inhibitors or inducers within 2 weeks prior to receiving the first dose of irinotecan liposome injection, or CYP3A4 inhibitors or UGT1A1 inhibitors within 1 week prior to receiving the first dose of irinotecan liposome injection, or those who could not suspend the above drugs during the study.
  • Patients who received systemic glucocorticoids (prednisone >10 mg/day or equivalent dose of the similar drugs) or other immunosuppressive agents within 14 days before the first dose of the study drug. Except for local, ocular, intra-articular, intranasal, and inhaled glucocorticoids, short term use of glucocorticoids for preventive treatment (e.g., prevention of contrast allergy). Cohort 2 in dose expansion is not limited.
  • Patients who have received prior topoisomerase I inhibitor treatment, including irinotecan or other investigational agents.
  • Known hypersensitivity (CTCAE 5.0≥3) to any of the components of irinotecan liposome injection, or other liposomal products.
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  • Patients with central Nervous System (CNS) metastasis meet any of the following criteria: Cohort 2 in dose expansion is not limited.
  • (1)Patients who have developed new or progressive brain metastasis following cranial radiation or surgery.
  • (2)Patients with the symptomatic Central Nervous System (CNS) metastasis who have used cortisol, radiotherapy, dehydration drugs, etc. to control symptoms in the past two weeks.
  • (3)Patients with carcinomatous meningitis.
  • (4)Patients with brainstem (midbrain, pons, medulla oblongata) metastasis.
  • (5)Patients have other evidence indicates that the patient's central nervous system metastasis or meningeal metastasis has not been controlled and is judged unsuitable for enrollment by the investigator.
  • 8.Patients who have pulmonary lymphatic dissemination and metastasis, leading to dyspnea at rest, may need to be combined with other treatments, such as oxygen inhalation, which is judged not suitable for enrollment by the investigator.
  • 9.Prior radiation therapy encompassing more than 30% of bone marrow.
  • 10.Patients have unresolved adverse reactions > grade 1 (CTCAE 5.0) from previous anti-tumor treatment (except for the peripheral neuropathy < grade 2, alopecia, and other toxicity judged no safety risk by investigators).
  • 11.History of autoimmune disease, immunodeficiency (including HIV test positive), or other acquired or congenital immunodeficiency, or organ transplantation.
  • 12.Patients with known Hepatitis B Virus (HBV DNA>2000 IU/ml), Hepatitis C Virus (anti-HCV positive), or other uncontrolled active infections.
  • 13.Chronic gastrointestinal dysfunction with diarrhea as the main symptom, such as Crohn's disease, ulcerative colitis, malabsorption or Diarrhea ≥ grade 1, intestinal obstruction, or other gastrointestinal diseases of clinical significance as judged by the investigators.
  • 14.Previous malignancies in the past five years (except basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or of others that have been radically resected and have not recurred).
  • 15.History of serious cardiovascular disease, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.
  • Patients with prolonged QT/QTc interval in baseline electrocardiogram (ECG) (QTcF > 480 ms, Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate).
  • Patients with myocardial infarction, angina pectoris, coronary angioplasty or stent, deep vein thrombosis, stroke within 6 months before enrollment.
  • Baseline echocardiography (ECHO) or cardiac radionuclide scanning (MUGA) techniques showed left ventricular ejection fraction (LVEF) ≤ 50%, or NYHA grade Ⅲ and above.
  • Poorly controlled hypertension (systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥ 95 mmHg with optimal treatment.
  • Previous or current cardiomyopathy.
  • Patients with clinically significant abnormal electrocardiogram (ECG)according to the investigator's assessment.
  • 16. Uncontrolled third lacunar effusion, improper for enrollment by investigator's assessment.
  • 17. Patients with alcohol or drug dependence.
  • 18. Pregnant or lactating women.
  • 19.History of explicit neurological or psychiatric disorders, including epilepsy or dementia.
  • 20. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration, or interfere with the interpretation of safety results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hosptial of CAMS

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Irinotecan Liposome Injection in Patients With Advanced Breast Cancer

This study is an open-label, single-arm, phase I study of irinotecan liposome injection in patients with advanced breast cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced breast cancer.

Read the detailed description

This is an open-label, single-arm, phase I study with a dose-escalation phase (part 1) and a dose-expansion phase (part 2). In part 1, patients will receive irinotecan liposome injection (CSPC) at the initial starting dose until progression or unacceptable toxicity. Dosages will be escalated by certain increments in subsequent cohorts. Once the appropriate dose has been established in part 1, patients will be enrolled into two expansion cohorts in part 2.

Being tested
Irinotecan Liposome Injection

What participants receive

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

  • Irinotecan Liposome InjectionDrug

    Irinotecan Liposome Injection

Study groups in NCT04728035
Study groupRoleWhat they receive
Dose escalation (part 1)ExperimentalPatients will receive irinotecan liposome injection (CSPC) at the initial starting dose until progression or unacceptable toxicity.
Receives: Drug: Irinotecan Liposome Injection
Dose expansion (part 2)ExperimentalOnce the appropriate dose has been established in Part 1, patients will be enrolled into two expansion cohorts according to the sub-type of breast cancer.
Receives: Drug: Irinotecan Liposome Injection

What is being measured

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

  1. Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)

    The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

    Measured: Up to six months after the last patient's first administration

  2. Dose limiting toxicity (DLT)

    DLT will be assessed according to NCICTCAE v5.0.

    Measured: Up to 28 days post-product injection

  3. Maximum Tolerated Dose (MTD, if available)

    MTD was defined as the previous dose level at which 2 out of 6 patients experienced a DLT.

    Measured: Up to 28 days post-product injection

  4. Recommended Phase 2 Dose (RP2D)

    RP2D was defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability data collected during the dose escalation portion of the study.

    Measured: Up to the end of the part 1

Secondary outcomes (12)

  1. Objective Response Rate (ORR)

    The percentage of patients who achieve a complete response (CR) or partial response (PR) based on the modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    Measured: Up to six months after the last patient's first administration

  2. Progression-Free Survival (PFS)

    Time from date of the first dose to date of recorded disease progression or death, whichever occurs first.

    Measured: Up to six months after the last patient's first administration

  3. Disease Control Rate (DCR)

    The percentage of patients who achieve a CR, PR or stable disease (SD) based on the modified RECIST 1.1.

    Measured: Up to six months after the last patient's first administration

  4. Duration of Response (DOR)

    Time from first documented response (CR or PR whichever occurs first, based on investigator's assessment using RECIST 1.1) to date of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to six months after the last patient's first administration

  5. Overall survival (OS)

    Time from date of the first dose to date of death from any cause.

    Measured: Up to six months after the last patient's first administration

  6. CNS objective response rate (CNS ORR)

    The percentage of patients who achieve a CR or PR based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) in Cohort 2 of dose expansion.

    Measured: Up to six months after the last patient's first administration

  7. CNS clinical benefit rate (CNS CBR)

    The percentage of patients who achieve a CR, PR or SD based on RANO-BM in Cohort 2 of dose expansion.

    Measured: Up to six months after the last patient's first administration

  8. The Area under the concentration-time curve from time zero to infinity (AUCinf)

    AUCinf of total irinotecan,wrapped irinotecan, free irinotecan and SN-38 will be measured for the test product .

    Measured: -30minutes~168hours

  9. The Maximum observed plasma concentration (Cmax)

    Cmax of total irinotecan，wrapped irinotecan, free irinotecan and SN-38 will be measured for the test product .

    Measured: -30 minutes~168 hours

  10. The terminal elimination half-life (T1/2)

    T1/2 of total irinotecan,wrapped irinotecan, free irinotecan and SN-38 will be measured for the test product.

    Measured: -30 minutes~168 hours

  11. The time to maximum concentration (Tmax)

    Tmax of total irinotecan,wrapped irinotecan, free irinotecan and SN-38 will be measured for the test product .

    Measured: -30minutes~168 hours

  12. The Apparent volume of distribution (Vd)

    Vd of total irinotecan will be measured for the test product.

    Measured: -30 minutes~168 hours

Timeline

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

  1. First posted28 Jan 2021
  2. Study start31 May 2021
  3. Primary completion5 Jun 2023
  4. Study completion5 Jun 2024

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04728035
Sponsor's protocol ID
HE072-CSP-002
Status last verified
Dec 2020
First submitted
18 Jan 2021
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fan Y, Zhang Q, Yan M, Qu X, Yin Y, Sun T, Yang J, Wang Y, Wang X, Niu Z, Wang X, Sun S, Zhao W, Liu Y, Niu M, Zhao X, Xu B. Intravenous liposomal irinotecan in metastatic triple-negative breast cancer after >/= 2 prior lines of chemotherapy: a phase Ib study. Nat Commun. 2025 Jan 2;16(1):3. doi: 10.1038/s41467-024-55090-4.

    PubMed 39746964

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Irinotecan Liposome Injection in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical 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 23 inclusion and 32 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 26 Jul 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?

Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to six months after the last patient's first administration). The study lists 4 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 NCT04728035, which also lists 1 linked publication.

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 26 Jul 2024.

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