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Oral Squamous Cell CarcinomaPhase 1NCT04413214

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

A Phase 1 study testing Carrimycin in people with Oral Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Carrimycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
20 Dec 2019to 30 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Carrimycin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarrimycinDrug

    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.

Study groups in NCT04413214
Study groupRoleWhat they receive
Test GroupExperimentalThe 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.
Receives: Drug: Carrimycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Two years

  2. 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).

    Measured: Four weeks

Secondary outcomes (2)

  1. Objective response rate to Carrimycin

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

    Measured: Four weeks

  2. 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

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start20 Dec 2019
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04413214
Sponsor's protocol ID
Clarion I
Status last verified
Dec 2021
First submitted
28 May 2020
Last updated
5 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Carrimycin in people with Oral Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04413214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.

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