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

Primary Purpose

Oral Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Carrimycin

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Objective response rate to Carrimycin

Including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)

Progression-free survival

The period between the time a patient with a cancer disease begins to receive treatment and observe the disease progression or die for any reason

Full Information

NCT ID

NCT04413214

First Posted

May 28, 2020

Last Updated

April 4, 2023

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04413214

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

December 20, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Carrimycin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events

Description

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.

Time Frame

Two years

Title

Dose limiting toxicity

Description

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

Time Frame

Four weeks

Secondary Outcome Measure Information:

Title

Objective response rate to Carrimycin

Description

Including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)

Time Frame

Four weeks

Title

Progression-free survival

Description

The period between the time a patient with a cancer disease begins to receive treatment and observe the disease progression or die for any reason

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lai-ping Zhong, PhD/MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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