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Advanced Solid TumorPhase 1NCT04638491

Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

A Phase 1 study testing Lurbinectedin for injection in people with Advanced Solid Tumor, run by Luye Pharma Group 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

Phase 1, single-arm, open-label, dose escalating and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of Lurbinectedin (PM01183) for injection in patients with advanced solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Lurbinectedin for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
24 Nov 2020to 4 Nov 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

  • 1. Voluntary written informed consent of the patient.
  • 2. Age≥18 years.
  • 3. Escalating stage: Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom refuses or cannot tolerate standard treatment or no standard therapy exist (no more than three prior regimens for advanced or unresectable disease).
  • 4. Expansion stage: Patients with histologically confirmed diagnosis of advanced or unresectable SCLC who had failure to one prior platinum -containing line.
  • 5. Measurable disease as defined by the RECIST v.1.1.
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
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  • 7. Life expectancy ≥3 months.
  • 8. Adequate bone marrow, renal, hepatic, and metabolic function as follows: Platelet count ≥ 100 x 109/l, Hemoglobin ≥ 90 g/l, absolute neutrophil count (ANC) ≥ 2.0 x 109/l; Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN), ≤ 5.0 x ULN if presence of liver metastases; Alkaline phosphatase ≤ 5.0 x ULN ; Total bilirubin ≤ 1.5 x ULN, and direct bilirubin ≤1 x ULN ; Serum creatinine ≤ 1.5 x ULN or Calculated creatinine clearance: ≥ 30 ml/min (calculated using the Cockcroft and Gault formula); Creatine phosphokinase (CPK) ≤ 2.5 x ULN; Albumin ≥ 3 g/dl.
  • 9. Recovery to grade ≤ 1 according to the NCI-CTCAE v.5.0, of any ongoing adverse event derived from previous treatment ( with the exception of grade 2 alopecia and non-painful peripheral sensory neuropathy ).
  • 10. Women of childbearing potential must have a negative serum pregnancy test before study entry. Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 6 months after discontinuation of treatment. Male patients (female partners is of childbearing potential ) take effective contraceptive measures throughout the treatment period and for 4 months after discontinuation of treatment.

Who cannot join

  • 1. Prior treatment with trabectedin.
  • 2. Patients with brain metastases, a history of spinal cord compression, or meningeal metastases.
  • 3. Suspected or confirmed disease bone marrow involved.
  • 4. Bone metastases, obstructive atelectasis, superior vena cava syndrome patients with local symptoms that may require radiotherapy/surgery/endoscopic treatment/interventional intervention; patients with suspected or confirmed pulmonary embolism; uncontrollable large amounts of pleural fluid, ascites and pericardial effusion.
  • 5. Patients who received other recent antitumor therapies ( with respect to study treatment start ) : Less than three weeks since the last chemotherapy-containing regimen (six weeks in case of nitrosoureas, mitomycin C ).
  • Less than four weeks since the last monoclonal antibody-containing therapy or radiotherapy (RT) dose >30 Gy.
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  • Less than two weeks since the last any other biological/investigational anticancer therapy or palliative radiotherapy ( total dose ≤30 Gy).
  • 6. Concomitant diseases/conditions: History (during the last year) or presence of any of the following: unstable angina, myocardial infarction, New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), or clinically significant valvular heart disease; History of stroke within 1 year (including ischemic stroke, hemorrhagic stroke); Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg); History of hypertensive crisis or hypertensive encephalopathy; Severe arrhythmia requiring ongoing pharmacological treatment; Positive tests for Hepatitis B surface antigen (HBsAg) and the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test is ≥1×103 copies/mL; if the HBsAg is positive, and the peripheral blood HBV DNA titer test is <1×103 copies/ml and in the Investigator's judgment, the patient is under a stable stage of chronic hepatitis B and does not increase the risk of the patient, then the patient is eligible for selection; HCV antibody positive or HIV antibody positive; Active uncontrolled infection requiring ongoing medical treatment within two weeks prior to treatment start.
  • Evidence of bleeding diathesis or significant coagulopathy; Prior or concurrent invasive malignancy other than the primary study indication within 5 years prior to treatment start, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection； Any other major illness that, in the Investigator's judgment, not suitable for inclusion in this study.
  • 7. History of previous bone marrow and/or stem cell transplantation.
  • 8. Prior medication requirements: Patients who have used strong inducers or inhibitors of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks or 5 half-lives ( whichever is longer ) prior to treatment start; Prophylaxis or treatment for non-febrile neutropenia with G-CSF within two weeks prior to treatment start; Patients who have used erythropoietin and derivatives within 3 weeks prior to treatment start; Patients who have used blood transfusions within 2 weeks prior to treatment start.
  • 9. Patients who may need to receive other systemic anti-tumor or radical treatments for local target/non-target lesions during the study period;
  • 10. Known history of psychotropic drug, alcohol or drug abuse;
  • 11. Known to be allergic to any component of the investigational drug;
  • 12. Pregnant or breastfeeding women, or women of childbearing potential have a positive blood pregnancy test.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jilin Provincial Tumor Hospital

    Changchun, Jilin

Other trials in China

About this study

Official title: Phase 1, Single-arm, Open-label, Dose Escalating and Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of Lurbinectedin (PM01183) for Injection in Patients With Advanced Solid Tumors

Phase 1, single-arm, open-label, dose escalating and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of Lurbinectedin (PM01183) for injection in patients with advanced solid tumors

Read the detailed description

To evaluate the safety and tolerability of PM01183 as a single agent, and to identify the dose limiting toxicities (DLTs), determine the recommended dose (RD) in Chinese advanced solid tumors patients

Being tested
Lurbinectedin for injection
Keywords
Lurbinectedin(PM01183) for injection

What participants receive

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

  • Lurbinectedin for injectionDrug

    Also called PM01183

    On the first day of each cycle, patients with advancedsolid tumors or small cell lung cancer were treated with Lurbinectedin for injection

Study groups in NCT04638491
Study groupRoleWhat they receive
single-armExperimentalPM01183-Dose Escalation
Receives: Drug: Lurbinectedin for injection

What is being measured

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

  1. Objective Response Rate(ORR)

    The number and percentage of subjects with significant remission (CR + PR) were calculated, and the 95% confidence interval of the percentage was calculat

    Measured: From date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months(each cycle is 21 days)

Secondary outcomes (4)

  1. Disease Control Rate(DCR)

    The number and percentage of subjects with disease control (CR+PR+SD) were calculated, and the 95% confidence interval of the percentage was calculated

    Measured: From date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months(each cycle is 21 days)

  2. Progression Free Survival(PFS)

    Survival analysis (Kaplan Meier method) was used to estimate the median dor and its 95% confidence interval (CI), and the K-M curve was drawn

    Measured: From date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months(each cycle is 21 days)

  3. Overall Survival(OS)

    Survival analysis (Kaplan Meier method) was used to estimate the median dor and its 95% confidence interval (CI), and the K-M curve was drawn

    Measured: From date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months(each cycle is 21 days)

  4. Duration of remission (DOR)

    Survival analysis (Kaplan Meier method) was used to estimate the median dor and its 95% confidence interval (CI), and the K-M curve was drawn

    Measured: From date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months(each cycle is 21 days)

Timeline

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

  1. First posted20 Nov 2020
  2. Study start24 Nov 2020
  3. Primary completion4 Nov 2023
  4. Study completion4 Nov 2023

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
Not applicable
Intervention model
Single group
Model description
Lurbinectedin for injection(PM01183)
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638491
Sponsor's protocol ID
LY01017/CT-CHN-101
Status last verified
Jun 2024
First submitted
5 Nov 2020
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheng Y, Wu C, Wu L, Zhao J, Zhao Y, Chen L, Xin Y, Zhang L, Pan P, Li X, Li J, Dong X, Tang K, Gao E, Yu F. A pivotal bridging study of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer. Sci Rep. 2024 Feb 13;14(1):3598. doi: 10.1038/s41598-024-54223-5.

    PubMed 38351146

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lurbinectedin for injection in people with Advanced Solid Tumor, run by Luye Pharma Group 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 10 inclusion and 15 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 10 Jun 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?

Objective Response Rate(ORR) (time frame: From date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months(each cycle is 21 days)). 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 NCT04638491, 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 10 Jun 2024.

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Clinical Trial NCT04638491 | AzTrials