To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer

NCT03020823 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: SCB01A-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous platinum based therapies.

Conditions

Head and Neck Neoplasms

Keywords

SCB01A; squamous cell carcinoma of head and neck

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) During Treatment Phase

  Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria. 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.

  Up to approximately 15 months (assessed continuously during treatment)

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  From the start of treatment up to either first observation of progressive disease or occurrence of death, up to approximately 15 months (assessed continuously during treatment)

• Overall Survival (OS)

  From the start of treatment up to death from any cause or last day known to be alive, up to approximately 15 months (assessed continuously during treatment)

• Best Overall Tumor Response

  Up to approximately 15 months (assessed continuously during treatment)

Study Arms (1)

SCB01A alone

EXPERIMENTAL

intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT

Drug: SCB01A

Interventions

SCB01A DRUG

intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Also known as: 6-Methoxy-3-(3',4',5'-trimethoxybenzoyl) indole

SCB01A alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥20 years;
• Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
• Histological or cytological confirmed squamous cell carcinoma of head and neck, excluding nasopharyngeal carcinoma;
• Subjects with unresectable, unfeasible radiotherapy, recurrent or metastatic head and neck squamous cell carcinoma, after previous treatment with platinum agent;
• Subjects must have at least one measurable tumor lesion as defined by RECIST version 1.1 as assessed by the investigator (local radiological image assessment) or clinically evaluable disease. Physical and neurological examinations, and radiographic studies have to be performed within 28 days of Cycle 1 Day 1;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;
• Life expectancy of 12 weeks or longer;
• Concurrent local therapy is not allowed, but concurrent palliative radiation therapy to non-measurable sites of disease such as painful bone metastasis is permitted;
• All eligible subjects of childbearing potential have to use effective contraception; that is, double barrier contraceptive methods;
• Documented progressive disease within past 6 months;
• Adequate bone marrow reserve, cardiac, renal and liver function:
• Absolute neutrophil count (ANC) \> 1.5 x 109/L;
• White blood cell (WBC) \> 3 x 109/L;
• Platelet count \> 75 x 109/L;
• Hemoglobin \> 9 g/dL ( \> 5.6 mmol/l);

You may not qualify if:

• Known primary CNS malignancy or CNS involvement (except for brain metastases that have been treated and are stable and subject is off steroids);
• Chemotherapy, radiation therapy, major surgery or investigational agents including immune or target therapies less than 4 weeks prior to study drug treatment;
• History of malignancy other than head and neck cancer with the exception of early stage non-melanoma skin cancer or carcinoma in situ of cervix;
• History of liver cirrhosis;
• Active hepatitis B or hepatitis C infection;
• Clinical significant pulmonary obstructive or clinical significant pulmonary restrictive diseases (grade \>2);
• Clinically significant cardiac disease (NYHA class \> 2);
• Other serious illness or medial conditions, such as active infection, unresolved bowel obstruction, or psychiatric disorders;
• Known HIV positivity;
• Pregnant or breast-feeding subjects, and men and women of child-bearing potential not using effective contraception while on study treatment;
• Known hypersensitivity to any component of SCB01A or excipients including Solutol®, alcohol, and PEG300;
• History of exposure to SCB01A or its analogues;
• History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere with the clinical and radiological evaluation of central nervous system during the trial;
• Peripheral neuropathy (≥ grade 2);
• Any other reason the investigator deems the subject to be unsuitable for the study.

Sponsors & Collaborators

• SynCore Biotechnology Co., Ltd.: lead

Study Sites (4)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Suang Ho Hospital

Taipei, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

indole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. Lin
• Organization: Syncore

JWLin@syncorebio.com

0227603688

Study Officials

• Her-Shyong Shiah, MD

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: April 30, 2017
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: June 5, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)