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

  • STATUS
    Recruiting
  • End date
    Oct 28, 2021
  • participants needed
    72
  • sponsor
    Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Updated on 26 January 2021
estrogen
measurable disease
tumor cells
epidermal growth factor receptor
human epidermal growth factor
erbb2
epidermal growth factor
estrogen receptor
lxi-15029
exemestane
locally advanced breast cancer

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. 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.

Details
Condition Advanced Breast Cancer
Treatment LXI-15029, LXI-15029+Exemestane
Clinical Study IdentifierNCT03125746
SponsorShandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Advanced Breast Cancer??
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
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

Exclusion Criteria

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
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
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