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

NCT04413214 | Completed Phase 1

• 1 other identifier: Clarion I
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 advanced, recurrent, or metastatic head and neck squamous cell carcinoma (non NPC).

Conditions

Oral Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events

  According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5.0, evaluate adverse events occurred during the whole study period.

  Two years

• Dose limiting toxicity

  According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5.0, observe the dose limiting toxicity (DLT).

  Four weeks

Secondary Outcomes (2)

• Objective response rate to Carrimycin

  Four weeks

• Progression-free survival

  Two years

Study Arms (1)

Test Group

EXPERIMENTAL

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.

Drug: Carrimycin

Interventions

Carrimycin DRUG

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.

Test Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

carrimycin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Lai-ping Zhong, PhD/MD

  Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: December 20, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 5, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)