NCT04413214

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

Safety and Efficacy Evaluation of Carrimycin in Patients With Locally Advanced, Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (Non NPC): A Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The trial is a study conducted to evaluate the safety, tolerability and PK characteristics of Carrimycin tablet and measure its anti-tumor efficacy initially in the treatment of patients with locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma (non NPC).

Detailed description

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.

Conditions

• Oral Squamous Cell Carcinoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Carrimycin	The study involves three dose groups: 200mg, 400mg and 600mg. Three patients are planned for each dose group. Starting from the low dose group, the treatment to three patients in the 200mg dose group: 200mg of Carrimycin after meals every morning (po) for three weeks, and then discontinue for one week, the tolerance and efficacy evaluation will be performed after the 4 weeks. DLT will be recorded during the 4 weeks.

Timeline

• Start date: 2019-12-20
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2020-06-02
• Last updated: 2023-04-05

Locations

1 site across 1 country: China