Study of SCB01A in Patient With Head and Neck Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCB01A

This study is a single arm, open-label, Phase II trial

Group Type EXPERIMENTAL

SCB01A

Intervention Type DRUG

This study is a single arm, open-label, Phase II trial

Interventions

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SCB01A

This study is a single arm, open-label, Phase II trial

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No