Head and Neck NeoplasmsPhase 2NCT03020823
To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer
A Phase 2 study testing SCB01A in people with Head and Neck Neoplasms, run by SynCore Biotechnology Co., Ltd. at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- SCB01A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesTaiwan
- Study dates
- 30 Apr 2017to 20 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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);
- Prothrombin time (PT)/international normalized ratio (INR) ≤1.5 x upper limit of normal (ULN);
- Creatinine clearance (Cockcroft \& Gault formula) >50 mL/min;
- Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) and Alkaline Phosphatase (ALP) < 3 x ULN; AST/ALT≦5 x ULN if liver metastasis;
- Serum albumin ≥ 3 g/dL;
- Total Bilirubin ≤ 1.5 x ULN;
- QTc <450 msec
Who cannot join
- 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);
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- 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.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
National Cheng Kung University Hospital
Tainan
Suang Ho Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
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
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.
Read the detailed description
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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- SCB01A
- Keywords
- SCB01A, squamous cell carcinoma of head and neck
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB01ADrug
Also called 6-Methoxy-3-(3',4',5'-trimethoxybenzoyl) indole
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SCB01A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 15 months (assessed continuously during treatment)
Secondary outcomes (3)
Progression Free Survival (PFS)
PFS is defined as the time from the start of treatment up to the date of first progression based on RECIST v1.1 or the date of death, which ever comes first.
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).
Measured: 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)
OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.
Measured: 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
Best overall tumor response is defined as an objective response or stable disease of treatment phase.
Measured: Up to approximately 15 months (assessed continuously during treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start30 Apr 2017
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Why it stopped: withdrawal by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- SynCore Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Her-Shyong Shiah, MD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020823
- Sponsor's protocol ID
- SCB01A-22
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2017
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03020823
- Acronym / sponsor ID
- SCB01A-22
- Conditions
- Head and Neck Neoplasms
- Keywords
- SCB01A, squamous cell carcinoma of head and neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: withdrawal by sponsor
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SynCore Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 2 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCB01A alone | Experimental | Drug: SCB01Aintra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCB01AAlso: 6-Methoxy-3-(3',4',5'-trimethoxybenzoyl) indoleintra-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. | Drug | SCB01A alone |
Primary outcome
Objective Response Rate (ORR) During Treatment Phase
Time frame: Up to approximately 15 months (assessed continuously during treatment)
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.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 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)
Time frame: 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
Time frame: Up to approximately 15 months (assessed continuously during treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Her-Shyong Shiah, MD principal investigator
Taipei Medical University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCB01A in people with Head and Neck Neoplasms, run by SynCore Biotechnology Co., Ltd. at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) During Treatment Phase (time frame: Up to approximately 15 months (assessed continuously during treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.