Study of SCB01A in Patient With Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

An Open-Label, Phase II Study to Evaluate SCB01A in Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Received Platinum-Based Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02488629
• Other study ID #: SCB01A-21
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2023
• Source: SynCore Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of SCB01A in head and neck cancer.

Description:

The study is designed to evaluate the safety and efficacy of SCB01A in patients with recurrent or metastatic squamous cell carcinoma in head and neck.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed squamous cell carcinoma of head and neck

2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.

3. At least one measurable tumor lesion according to RECIST

4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status

5. All eligible patients of childbearing potential have to use effective contraception

6. Signed informed consent before enrolment

Exclusion Criteria:

1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents

2. Severe pulmonary obstructive or restrictive disease

3. Uncontrolled inflammatory disease

4. Clinically significant cardiac disease

5. Results of laboratory tests

6. Pregnancy or nursing status

7. Known hypersensitivity to any component of SCB01A

8. History of exposure to SCB01A or its analogues

9. History of malignancy other than head and neck cancer

10. History of active or significant neurological disorder or psychiatric disorder

11. Any other reason the investigator deems the patient to be unsuitable for the study

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• SCB01A
This study is a single arm, open-label, Phase II trial

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospital & lovers lake branch	Keelung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	MacKay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
SynCore Biotechnology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate (DCR)	To assess the DCR (=complete response (CR) + partial response (PR) + stable disease (SD)) at the end of the 9th week (3 cycles, each cycle consisted of 21 days) after treatment with SCB01A, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sumdiameterswhile on study.	9 weeks from 1st administrationm drug
Secondary	To Assess the Overall Survival Rate	To assess the overall survival (OS) rate at 36 weeks after first treatment with SCB01A in patients with recurrent or metastatic squamous cell head and neck cancer who have previously been treated with platinum therapy.	an expected average of 36 weeks
Secondary	To Assess the Progression-free Survival According to RECIST v.1.1	RECIST v.1.1: Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).	an expected average of 12 weeks