To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03020823|
Recruitment Status : Withdrawn (withdrawal by sponsor)
First Posted : January 13, 2017
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: SCB01A||Phase 2|
From pre-clinical pharmacology and phase I clinical study SCB01A has demonstrated promising anticancer action with a vascular disrupting activity that has the potential for treatment of various malignancies, particularly for patients with drug resistance. The drug has been studied in human subjects in a dose escalation phase I study and has shown to be safe for up to 2 cycles of 24 mg/m2 (each cycle consisting of one intravenous [i.v.] administration of SCB01A via a central line every 3 weeks). In the phase I study, partial response (PR) (shrinkage of tumor size to 50%) was observed in cycle 9 (3 mg/m2) of one subject with right buccal squamous cell carcinoma and 19/33 (58%) subjects had stable disease (SD) for more than 2 cycles.
Pre clinical study of SCB01A showed that the concentrations at which tubulin inhibition occurred were around 80 nM for 24-hour exposure or 200 nM for 6-hour exposure. However, pharmacokinetic (PK) results of phase I study showed that the average elimination half-life (t1/2) of a 3-hours i.v. infusion of SCB01A is approximately 2.5 hours and almost no SCB01A can be detected after 10 hours, indicating most subjects were treated in short API exposure time and may have been insufficient to achieve efficacy. Therefore, to extend the exposure duration above effective concentration in blood may increase the treatment efficacy.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase II Study to Evaluate the Efficacy and Safety of SCB01A in Subjects With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Failed Platinum-Based Treatment|
|Estimated Study Start Date :||April 30, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: SCB01A alone
intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
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.
Other Name: 6-Methoxy-3-(3',4',5'-trimethoxybenzoyl) indole
- Objective response rate (ORR) during treatment phase [ Time Frame: 2 years ]
- Progression free survival (PFS) [ Time Frame: 2 years ]
- Overall survival (OS) [ Time Frame: 2 years ]
- Best overall tumor response [ Time Frame: 2 years ]
- Safety assessed by changes in Laboratory Data, AE/SAE Incidences, Physical Examination, Vital Sign, and Electrocardiogram [ Time Frame: 2 years ]
- AE/SAE incidence
- Physical examination result changes
- Vital sign changes
- Electrocardiogram (ECG) (including PR, QRS, QTc intervals) results
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): NCT03020823
|Principal Investigator:||Her-Shyong Shiah, MD||Taipei Medical University Hospital|