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Advanced Breast CancerPhase 1NCT03125746

A Study of LXI-15029 in Patients With Advanced Malignant Solid Tumors

A Phase 1 study testing LXI-15029 and LXI-15029+Exemestane in people with Advanced Breast Cancer, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

1. To evaluate the safety and tolerability of LXI-15029 in Chinese patients with advanced malignant solid tumors in monotherapy period, including confirmation of the maximum tolerated dose (MTD) of monotherapy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Advanced Breast Cancer
What is being tested?
LXI-15029 and LXI-15029+Exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
12 Jun 2017to 28 Oct 2021
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Monotherapy Period
  • Patients with signed written informed consent form;
  • Chinese man or woman, aged 18 to 65 years old;
  • Patient with histologically or cytologically confirmed, advanced solid tumor after failure of standard of care or without standard of care;
  • Patients must have at least one measurable lesion as defined by RECIST v1.1 (during dose escalation phase,no measurable lesion as defined by RECIST v1.1 but evaluable lesion could also been enrolled);
  • Expected survival no less than 12 weeks;
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  • Eastern Cooperative Oncology Group (USA) Performance Status 0 to 1;
  • Patient of childbearing potential (regardless of man or woman) who is willing to take contraceptive measures from signature of the informed consent form to 3 months after the last dose of investigational product. Negative serum pregnancy test within 7 days prior to the planned first dose of investigational product for female patient of childbearing potential;
  • Have the ability to communicate with study staff, understand and comply with all the study requirements;
  • Combined with Exemestane period
  • Patients with signed written informed consent form;
  • Chinese patients aged postmenopausal women to 65 years old;
  • Postmenopausal patient;
  • Histologically or cytologically confirmed metastatic or locally advanced breast cancer that is not suitable for surgery or radiotherapy;
  • Estrogen receptor (+), defined as tumor cells with estrogen receptor (+) ≥1% in immunohistochemistry;
  • HER2-negative (Human epithelial growth factor receptor 2-negative) tumor;
  • Measurable lesions in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
  • Expected survival no less than 12 weeks;
  • Eastern Cooperative Oncology Group (USA) Performance Status 0 to 1;
  • Have the ability to communicate with study staff, understand and comply with all the study requirements;

Who cannot join

  • Monotherapy Period:
  • Previous antitumor therapy or any surgical operation within 4 weeks prior to administration of the first dose of study drug;
  • Treatment with myeloid hematopoietic growth factor within 2 weeks prior to use of investigational product;
  • Patients receiving corticosteroids or immunosuppressive agents within 4 weeks prior to administration of the first dose of study drug;
  • Use of potent-to-moderate cytochrome metabolism enzyme CYP3A4 inhibitor and inducer prior to treatment or during washout period;
  • Known allergy to LXI-15029 or similar products (mammalian target of rapamycin (mTOR) inhibitor or dual mTOR inhibitor) or other components of LXI-15029;
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  • Previous or receiving of PI3K or mTOR inhibitors (e.g., BKM120, everolimus, AZD8055 or AZD2014, etc.);
  • History, symptoms or signs of spinal compression, brain metastasis or meningeal metastasis, or manifestations of edema or progression in radiology;
  • History of other tumors within 5 years, except cured carcinoma in situ of cervix or cutaneous basal cell carcinoma;
  • The toxicity induced by treatment unable to be recovered or stabilized to grade 1 or below except alopecia (common terminology criteria on adverse event version 4.03 (CTCAE 4.03));
  • Hemotology and coagulation abnormal defined in protocol;
  • Hepatic function abnormal defined in protocol;
  • Renal function abnormal defined in protocol;
  • Cholesterol > 300 mg/dl or 7.75 mmol/L, and/or triglyceride > 2.5 × ULN;
  • Previous history of type 1 or 2 diabetes, or abnormal fasting blood glucose >126 mg/dL(>7 mmol/L) at screening;
  • Cardiovascular system diseases;
  • Patients with active upper peptic ulcer, refractory nausea and vomiting, or other conditions that were known to affect absorption, distribution, metabolism or elimination of drugs;
  • Patients with chronic obstructive emphysema, pulmonary fibrosis or pneumonia that could significantly affect pulmonary function at discretion of the investigator;
  • Infectious Diseases defined in protocol;
  • Judged by the investigator, any other serious or uncontrolled acute or chronic disease, or laboratory abnormality (including but not limited to cardiovascular, hepatic and renal, as well as neuromuscular system), and alcohol consumption, drug abuse that could possibly increase the risk for study or interfere with study conduction and result analysis;
  • Pregnant or lactating women;
  • Previous enrollment in this study or participation in this investigational therapy;
  • Participation in other clinical study during the last 30 days prior to Visit 1
  • At discretion of the Investigator, the patient is unsuitable for participation in this study for any reasons;
  • Patient of poor compliance.
  • Combined with Exemestane period
  • Previous antitumor therapy or any surgical operation within 4 weeks prior to administration of the first dose of study drug;
  • Treatment with myeloid hematopoietic growth factor within two weeks prior to use of investigational product;
  • Patients receiving corticosteroids or immunosuppressive agents within 4 weeks prior to administration of the first dose of study drug;
  • Use of potent-to-moderate cytochrome metabolism enzyme CYP3A4 inhibitor and inducer prior to treatment or during washout period
  • Previous use of Exemestane tablet;
  • Known allergy to LXI-15029 or similar products (mTOR inhibitor or dual mTOR inhibitor) or other component of LXI-15029;
  • Previous or receiving of PI3K or mTOR inhibitors (e.g., BKM120, everolimus, AZD8055 or AZD2014, etc.;
  • Visceral crisis of breast cancer, not suitable for endocrine therapy;
  • Inflammatory breast cancer;
  • History, symptoms or signs of spinal compression, brain metastasis or meningeal metastasis, or manifestations of edema or progression in radiology;
  • History of other tumors within 5 years, except cured carcinoma in situ of cervix or cutaneous basal cell carcinoma;
  • Exclusion criteria on concomitant disease and organ function:
  • The toxicity induced by treatment unable to be recovered or stabilized to grade 1 or below except alopecia (CTCAE 4.03);
  • Hemotology and coagulation abnormal defined in protocol;
  • Hepatic function abnormal defined in protocol;
  • Renal function abnormal defined in protocol;
  • Cholesterol > 300 mg/dl or 7.75 mmol/L, and/or triglyceride > 2.5 × ULN;
  • Previous history of type 1 or 2 diabetes, or abnormal fasting blood glucose >126 mg/dL(>7 mmol/L) at screening;
  • Cardiovascular system abnormal defined in protocol;
  • Patients with active upper peptic ulcer, refractory nausea and vomiting, or other conditions that were known to affect absorption, distribution, metabolism or elimination of drugs;
  • Patients with chronic obstructive emphysema, pulmonary fibrosis or pneumonia that could significantly affect pulmonary function at discretion of the investigator;
  • Infectious Diseases defined in protocol;
  • Judged by the investigator, any other serious or uncontrolled acute or chronic disease, or laboratory abnormality, and alcohol consumption, drug abuse that could possibly increase the risk for study or interfere with study conduction and result analysis;
  • Previous enrollment in this study or participation in this investigational therapy;
  • Participation in other clinical study during the last 30 days prior to Visit 1
  • At discretion of the Investigator, the patient is unsuitable for participation in this study for any reasons;
  • Patient of poor compliance.

Trial locations and contacts

1 site in 1 country.

Wenliang Wang, Master contact

86-21-61060190 ext. 8512

wenliangwang@luoxinbio.com

China1 site, 1 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Binghe Xu, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles and the Antitumor Activity of LXI-15029 Alone or in Combination With Exemestane at Single Ascending Dose and Multiple Ascending Doses in Chinese Patients With Advanced Malignant Solid Tumors

  1. To evaluate the safety and tolerability of LXI-15029 in Chinese patients with advanced malignant solid tumors in monotherapy period, including confirmation of the maximum tolerated dose (MTD) of monotherapy. 2.To evaluate the safety and tolerability of LXI-15029 in Chinese postmenopausal patients with metastatic or locally advanced breast cancer with estrogen receptor (+) and human epidermal growth factor receptor 2 (-) in combined with Exemestane period , including confirmation of the maximum tolerated dose(MTD) of the combined therapy with Exemestane.
Being tested
LXI-15029, LXI-15029+Exemestane

What participants receive

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

  • LXI-15029Drug

    The investigational product for this study is LXI-15029 capsule, which can be administered orally and the specification included 10 mg and 50 mg. There will be about 6 cohorts during the monotherapy period. LXI-15029 capsules will be administered in a therapeutic cycle of 28 days twice a day orally. The patients will be given LXI-15029 continuously, in a therapeutic cycle of 28 days. Patients will continue therapy with LXI-15029 if good safety and tolerability were assessed by investigators after 1 cycle treatment. The treatment will continue until progression or occurrence of unmanageable toxicity.

  • LXI-15029+ExemestaneDrug

    The combined drug in the combined therapy period of this study (investigational product) is Exemestane tablet (specification 25 mg). Exemestane should be taken at similar time every day in case of multiple doses (Cycle 1 Day 1 to Cycl 1 Day 28). If one dose was missed (e.g., forgetting, vomiting, etc.), this dose could not be made up and should be administered at next scheduled time point. And the dose of LXI-15029 will be determinated by safety review committee after dose escalation

Study groups in NCT03125746
Study groupRoleWhat they receive
LXI-15029ExperimentalNot described
Receives: Drug: LXI-15029
LXI-15029+ExemestaneExperimentalNot described
Receives: Drug: LXI-15029+Exemestane

What is being measured

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

  1. Number of participants with adverse events

    To evaluate the safety and tolerability of LXI-15029 through evaluation of the incidence and severity of adverse event (Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE, 4.03))

    Measured: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.

Secondary outcomes (3)

  1. Maximum Concentration (Cmax)

    Characterising the pharmacokinetics (PK) profile of LXI-15029

    Measured: When subject complete 1 cycle (28 days) treatment

  2. Area Under the Curve (AUC)

    Characterising the pharmacokinetics (PK) profile of LXI-15029

    Measured: When subject complete 1 cycle (28 days) treatment

  3. Tmax

    Characterising the pharmacokinetics (PK) profile of LXI-15029

    Measured: When subject complete 1 cycle (28 days) treatment

Timeline

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

  1. First posted24 Apr 2017
  2. Study start12 Jun 2017
  3. Primary completion28 Oct 2021 (estimated)
  4. Study completion28 Oct 2021 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03125746
Sponsor's protocol ID
OE861501
Status last verified
Dec 2020
First submitted
31 Mar 2017
Last updated
5 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang J, Gui L, Mu Y, Wang J, Chi Y, Liu Z, Li Q, Xu B. Phase I dose escalation study and pilot efficacy analysis of LXI-15029, a novel mTOR dual inhibitor, in Chinese subjects with advanced malignant solid tumors. BMC Cancer. 2023 Dec 6;23(1):1200. doi: 10.1186/s12885-023-11578-8.

    PubMed 38057772

  • Zhang Q, Zhang Y, Chen Y, Qian J, Zhang X, Yu K. A Novel mTORC1/2 Inhibitor (MTI-31) Inhibits Tumor Growth, Epithelial-Mesenchymal Transition, Metastases, and Improves Antitumor Immunity in Preclinical Models of Lung Cancer. Clin Cancer Res. 2019 Jun 15;25(12):3630-3642. doi: 10.1158/1078-0432.CCR-18-2548. Epub 2019 Feb 22.

    PubMed 30796032

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LXI-15029 and LXI-15029+Exemestane in people with Advanced Breast Cancer, run by Shandong Luoxin Pharmaceutical Group Stock 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 20 inclusion and 53 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 5 Jan 2021. 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?

Results are not available in the source record.

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

Contact Wenliang Wang, Master (86-21-61060190 ext. 8512, wenliangwang@luoxinbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.). 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 NCT03125746, which also lists 2 linked publications.

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 5 Jan 2021.

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