Status:
UNKNOWN
Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in c...
Eligibility Criteria
Inclusion
- Small cell lung cancer patients.
- The clinical stage at baseline is extensive.
- A measurable lesion.
- Disease progression.
- ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- Adequate laboratory indicators.
- No pregnant or breastfeeding women, and a negative pregnancy test.
- Understood and signed an informed consent form.
Exclusion
- Has used topotecan and anlotinib hydrochloride capsules.
- Has used other anti-angiogenic drugs and immunologically targeted drugs.
- Has other malignant tumors within 5 years.
- Symptomatic brain metastasis.
- Has a variety of factors affecting oral medications.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Spinal cord compression.
- Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
- Adverse events caused by previous treatment did not recover to grade 1.
- Has received major surgical treatment within 4 weeks before randomization.
- Arteriovenous thrombosis occurred within 6 months.
- Has drug abuse history that unable to abstain from or mental disorders.
- Has severe or uncontrolled disease.
- Participated in other clinical trials within 4 weeks.
- Tumor invades the large blood vessels.
- Daily hemoptysis ≥2.5 mL within 1 month before the first dose.
- According to the investigators' judgement.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04073550
Start Date
October 31 2019
End Date
July 31 2022
Last Update
August 29 2019
Active Locations (2)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100083
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100083