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Carrimycin in Patients With Locally Advanced Recurrent or Metastatic HNSCC (Non NPC): A Phase I Trial

Carrimycin in Patients With Locally Advanced Recurrent or Metastatic HNSCC (Non NPC): A Phase I Trial

Recruiting
18-75 years
All
Phase 1

This study is a prospective open phase-I study to investigate the safety, tolerability and PK characteristics of Carrimycin tablet in the treatment of patients with locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma (non NPC). The 3x3 dose escalation design will be adopted, including 200mg, 400mg and 600mg of Carrimycin; and three subjects at each dose level initially. If there is no DLT in the dose level of 200mg, the dose level of 400mg will be followed; if there is one DLT in the dose level of 200mg, another three patients will be added in the dose level of 200mg; if there is no DLT occurs in the another three patients, the dose level of 400mg will also be followed; if there is one DLT in the another three patients, the trial will be closed. The same condition to the dose level of 400mg and 600mg. If a patient fails to receive the full prescribed dose for reasons other than DLT at the time of the first administration, the patient will be replaced. Carrimycin treatment to the patients with DLT will be discontinued immediately and they will enter the follow-up period and will not be replaced. The study consists of screening period, treatment period and follow-up period. The treatment period continues until the patients develop progressive disease, dies, lost to follow-up or withdraw informed consent.

Study details
    Head and Neck Squamous Cell Carcinoma
    Oral Squamous Cell Carcinoma

NCT04413214

Shanghai Jiao Tong University School of Medicine

19 February 2024

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