Carrimycin in Patients With Locally Advanced, Recurrent, or Metastatic HNSCC (Non NPC): A Phase I Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04413214|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : December 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oral Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma||Drug: Carrimycin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 20, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Experimental: Test Group
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.
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.
- Incidence of treatment-emergent adverse events [ Time Frame: Two years ]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 [ Time Frame: Four weeks ]According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5.0, observe the dose limiting toxicity (DLT).
- Objective response rate to Carrimycin [ Time Frame: Four weeks ]Including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)
- Progression-free survival [ Time Frame: Two years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413214
|Contact: Ying Liu, Master||00862123271699 ext email@example.com|
|Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Lai-ping Zhong, MD, PhD +86-21-23271699 ext 5160 firstname.lastname@example.org|
|Contact: Ying Liu, MD +86-21-23271699 ext 5160 email@example.com|
|Principal Investigator: Lai-ping Zhong, MD, PhD|
|Principal Investigator:||Lai-ping Zhong, PhD/MD||Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine|