Status:
COMPLETED
Carrimycin in Patients With Locally Advanced, Recurrent, or Metastatic HNSCC (Non NPC): A Phase I Trial
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Oral Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ...
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 met...
Eligibility Criteria
Inclusion
- Locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma (non NPC) confirmed by histopathological or cytological diagnosis
- Expected life expectancy is no less than 6 months;
- ECOG PS is 0, 1 or 2;
- Subjects should be enrolled at least 4 weeks after the lastest treatment of surgery, radiotherapy, chemotherapy, or biotherapy, etc.
- The laboratory inspection indexes should meet the following requirements: Leukocyte\>3×109/L, Neutrophils\>1.5×109/L, Platelet count\>75×109/L，Hemoglobin\>80g/L, Serum total bilirubin\<1.5ULN, ALT or AST\<2.5ULN, Creatinine\<2.0ULN, BUN\<2.0ULN, Maximum extension of APTT normal is within 10s, Maximum extension of PT normal is within 3s.
- Women of reproductive age (18-45 years) must have a negative urine pregnancy test and agree to receive effective contraception. Male subjects must voluntarily receive appropriate contraception.
Exclusion
- There is still any undiminished CTCAE grade 2 or higher toxicity from previous anti-cancer treatments;
- There are significant cardiovascular abnormalities (e.g. myocardial infarction, upper-cavity venous syndrome, heart disease of grade 2 or higher diagnosed according to the New York Heart Association (NYHA) classification criteria 3 months prior to enrollment);
- There is active severe clinical infection (\>NCI-CTCAE V5.0 Level 2)
- Urine routine shows albuminuria ≥ ++, but if albuminuria at baseline ≥ ++, patients with albuminuria /24h\<1g measured quantitatively based on 24-hour urine collection can be enrolled;
- Allergic to macrolides;
- Uncontrolled hypertension (systolic \> 150 mmHg and / or diastolic \>100mmHg) or clinically significant (e.g. active) cardiovascular diseases - such as stroke (≤ 6 months before randomization), myocardial infarction (≤ 6 months before randomization), unstable angina pectoris, congestive heart failure of New York Heart Association (NYHA) functional class III or above, or serious arrhythmia that cannot be controlled with drugs or has potential impact on trial treatment.
- Known to have acute or chronic active HBV or HCV infection and need antiviral treatment with non nucleoside drugs;
- Women pregnant or lactation;
- Having participated in other clinical studies and received any other investigational drug for treatment within 30 days before enrollment;
- Having taken macrolide antibiotics (azithromycin, erythromycin, roxithromycin, clarithromycin, dirithromycin, spiramycin, acetylspiramycin, midecamycin, rokitamycin, meleumycin, josamycin, leucomycin, miocamycin) within 3 days before enrollment;
- Other cases considered inappropriate by the investigator to participate in the study.
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04413214
Start Date
December 20 2019
End Date
December 30 2022
Last Update
April 5 2023
Active Locations (1)
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1
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011