NCT03566576

Phase I Study of the Combination of Anlotinib With Pemetrexed or Docetaxel

Dose Climbing Trial of Anlotinib Plus Pemetrexed/Docetaxel in the Second-line Treatment of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the tolerability and toxicity of different dose of Anlotinib puls Pemetrexed/Docetaxel in Second-line Treatment of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer , to provide a reference of dosage for Phase II clinical trials

Detailed description

This is a randomized, single -center study conducted in China to compare the tolerability and toxicity of different dose of Anlotinib Plus Pemetrexed / Docetaxel in patients of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer.From low dose group up to high dose group, each one had 3 patients at least.Primary group received anlotinib 8mg. The dose of Anlotinib would increase gradually until MTD. Eligible patients will be randomized to arm A and arm B: Arm A: Patients were instructed to take folic acid 400ug orally daily beginning 1 week before the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. A 1000ug B12 injection was administered intramuscularly approximately 1 week before the first dose of pemetrexed and was repeated approximately every 9 weeks until after discontinuation. All target volumes were instructed to take dexamethasone (4 mg orally twice daily the day before, the day of, and the day after pemetrexed) as a prophylactic measure against skin rash. Patients on the pemetrexed arm received 500mg/m2 pemetrexed as a 10-minute intravenous infusion on day 1 of a 21-day cycle and 8mg/10mg/12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycle. Arm B: Patients on the docetaxel arm received 60mg/m2 docetaxel as a 10-minute intravenous infusion on day 1 of a 21-day cycle and 8mg/10mg/12mg anlotinib orally daily on day 1to 14 of a 21-day cycle. Approximately 18 patients will be enrolled to ensure that roughly 9 patients per arm complete treatments for primary endpoint analysis.

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib 8mg p.o. qd in first cohort (3 subjects). 10mg p.o. qd in second cohort (3 subjects). 12mg p.o. qd in third cohort (3 subjects).
DRUG	Pemetrexed	Pemetrexed 500mg/m2 as a 10-minute intravenous infusion on day 1 of a 21-day cycle.
DRUG	Docetaxel	Docetaxel 60mg/m2 as a 10-minute intravenous infusion on day 1 of a 21-day cycle.

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2018-06-25
• Last updated: 2018-06-25