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Study on the plasma concentration therapeutic window of anlotinib in treated with non-small cell lung cancer and its influencing factors based on the PK/PD model

Study on the plasma concentration therapeutic window of anlotinib in treated with non-small cell lung cancer and its influencing factors based on the PK/PD model

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043709
Enrollment
Unknown
Registered
2021-02-27
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

case series:Nil

Sponsors

Hangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: From June 2021 to June 2023, NSCLC patients treated with amrotinib in outpatient or inpatient departments of cardiothoracic surgery and respiratory medicine in our hospital mainly had the following inclusion criteria: 1. Patients who voluntarily participated in the study and signed the informed consent; 2. Patients with advanced (IIIB or IV) NSCLC with measurable target lesions; 3. Patients who received >= 2 chemotherapy regimens or were unable to tolerate chemotherapy; 4. For patients with EGFR mutation or ALK mutation positive, amlotinib should be used after progression after receiving the corresponding targeted drug therapy and progression or recurrence after at least 2 systemic chemotherapy; 5. Patients aged 18-75 years, the expected survival time >= 3 months; 6. Anlotinib was given 8mg, 10mg or 12mg every time, once a day, combined for 2 weeks and stopped for 1 week, every 3 weeks as a course of treatment. 7. Enrolled patients were required to extract 2ml of plasma on day 1 of the first cycle of amlotinib administration (30min before administration), day 14 of treatment (30min before administration, 2h, 6h, 10h and 24h after administration) and day 22 (30min before administration of the next cycle), and 2ml of whole blood was collected for DNA extraction. Meanwhile, clinical efficacy and adverse reactions were regularly evaluated.

Exclusion criteria

Exclusion criteria: 1. Patients with previous use of arotinib; 2. Patients with small cell lung cancer, including non-small cell lung cancer and small cell lung cancer; 3. Patients with EGFR gene mutation or ALK mutation were not treated with corresponding targeted drugs; 4. Patients scheduled for systemic anti-tumor therapy before or within 4 weeks of this study, including cytotoxic drugs, signal transduction inhibitors and immunotherapy (or 6 weeks before administration); The patients were treated with ef-rt four weeks before the treatment, and the patients were treated with limited radiotherapy two weeks before the treatment.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
security;

Countries

China

Contacts

Public ContactJiang Lou

Hangzhou First People's Hospital

jianglou5855@163.com+86 15868140043

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026