- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216082
A Study of Anlotinib in Subjects With Advanced Malignancy
A Single Center, Single-arm, Phase II Study of Anlotinib in Subjects With Advanced Malignancy
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) 18~70 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
2) Histopathologically confirmed advanced malignancy, including gynecological-related tumors, breast cancer, digestive tract tumors, melanoma, and gastrointestinal stromal tumors.
3) Has no effective treatment choice, or failure/recurrence after conventional treatment.
4) If has received chemotherapy, the treatment has been discontinued for at least 30 days.
5) The main organs function are normally. 6) Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
7) Understood and signed an informed consent form.
Exclusion Criteria:
1)Has other malignant tumors. 2) Has participated in other anticancer drug clinical trials within 4 weeks. 3) Has multiple factors affecting oral medication. 4) Has brain metastasis, spinal cord compression, cancerous meningitis. 5) Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
6) Has any serious and / or uncontrolled disease. 7) Long-term unhealed wounds or fractures. 8) Has artery/venous thrombosis prior to the first dose within 6 months. 9) Has bleeding tendency or treated with anticoagulants or vitamin K antagonists.
10) Has drug abuse history that unable to abstain from or mental disorders. 11)Has history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
12) According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Anlotinib
Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
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Anlotinib is a oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis as well as cell proliferation simultaneously and have been approved to treat advanced non-small cell lung cancer (NSCLC) in China.
Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: up to 96 weeks
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Percentage of subjects achieving complete response (CR) and partial response (PR).
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up to 96 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response (DOR)
Time Frame: up to 96 weeks
|
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
|
up to 96 weeks
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Disease control rate(DCR)
Time Frame: up to 96 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
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up to 96 weeks
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Progression-free survival (PFS)
Time Frame: up to 96 weeks
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PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
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up to 96 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTN-00-II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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