Phase I Study of the Combination of Anlotinib With Gefitinib
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|ClinicalTrials.gov Identifier: NCT03602027|
Recruitment Status : Unknown
Verified July 2018 by Second Affiliated Hospital of Nanchang University.
Recruitment status was: Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-squamous Non-small Cell Lung Cancer||Drug: Anlotinib Drug: Gefitinib||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Climbing Trial of Anlotinib Plus Gefitinib in the First-line Treatment of Advanced Gene Positive Non-squamous Non-small Cell Lung Cancer|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||February 1, 2019|
Experimental: Anlotinib Plus Gefitinib
This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day and Gefitinib. middle-dose groups: Anlotinib 10mg per day and Gefitinib. high-dose groups: Anlotinib 12mg per day and Gefitinib.
A dose limiting toxicity (DLT) event is defined as any of the following events:
Anlotinib 8mg p.o. qd in low-dose groups (3 subjects). 10mg p.o. qd in middle-dose groups (3 subjects). 12mg p.o. qd in high-dose groups (3 subjects).
Gefitinib 250mg orally daily for three weeks
- Dose limiting toxicity [ Time Frame: From enrollment to completion of study. Estimated about 4 months. ]Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria
- Maximum tolerance dose [ Time Frame: From enrollment to completion of study. Estimated about 4 months ]Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.
- disease control rate [ Time Frame: From enrollment to 2 months after treatment ]Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate)
- time to progression [ Time Frame: From enrollment to progression of disease. Estimated about 6 months ]The length of time from enrollment until the time of progression of disease (TTP, time to progression).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602027
|Contact: Liu An email@example.com|