Status:
COMPLETED
A Phase I Study of LX-039 Tablets
Lead Sponsor:
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary ant...
Eligibility Criteria
Inclusion
- Be able to read and sign the informed consent form.
- Adult females (aged ≥18 and ≤75 years).
- Be diagnosed with breast cancer confirmed by pathological examination.
- Be histologically or cytologically confirmed estrogen receptor positive (ER+≥1% positive staining).
- Be postmenopausal.
- Subjects who have previously received endocrine therapy and obtained benefit.
- ECOG(Eastern Cooperative Oncology Group) score ≤ 1.
- Subjects in part2 of the study need to have measurable lesions that meet RECIST 1.1 criteria.
- Has recovered from toxicity or injury from prior chemotherapy/radiotherapy .
- Enough hematology and organ function.
- Expected survival\>3 months.
Exclusion
- Subjects with HER2-overexpressing breast cancer.
- Subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated.
- Patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications.
- Subjects who received second-line or above chemotherapy.
- Subjects with known allergy to this product or any of its components.
- Subjects who previously used other estrogen receptor down regulators than fulvestrant.
- Subjects who received endocrine therapy or other anti-tumor agent or radiotherapy within 4 weeks prior to study entry.
- Subjects who received cell therapy or tumor vaccine therapy;
- Subjects with severe immunosuppression .
- Severe or uncontrolled disease.
- Subjects with diseases or abnormalities that may affect the administration and absorption of drugs.
- Subjects with other malignancy within 5 years prior to study entry.
- Subjects with other high risks of thrombosis or require long-term use of antiplatelet drugs.
- Subjects with history of definite neurological or psychiatric disorders in the past.
- Subjects who are HIV(human immunodeficiency virus) antibody positive, HBsAg(hepatitis B surface antigen) positive or HCV(hepatitis C virus)antibody positive.
- Subjects with other uncontrolled malignant/non-malignant diseases, significant laboratory abnormalities, participation in the study may increase the risk.
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04097756
Start Date
January 7 2020
End Date
February 7 2023
Last Update
May 1 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032