Advanced CancerPhase 1NCT02469883
A Study of Sinotecean on Tolerance and Pharmacokinetics
A Phase 1 study testing Sinotecean in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Sinotecean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- late malignant tumor patients diagnosed with the pathological and/or cytological;
- lack of the standard treatment or treatment failure;
- 18-65years, ECOG:0-1,expected survival period >3 months;
- main organs function is normal;
- signed and dated informed consent
Who cannot join
- participated in other clinical trials in four weeks;
- currently under other effective treatment;
- end of anti-tumor treatment within 4 weeks(end of Nitrosourea/Mitomycin within 6 weeks);
- AE ≥ Grade 2(according to NCI-CTC 4.0),except hair loss;
- with ischemic heart disease, heart failure, severe arrhythmia, cerebrovascular disease, asthma, severe infections, active peptic ulcer;
- urine protein: ++, and urinary in 24 hours > 1.0g;
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- uncontrolled primary or metastatic brain;
- have immunodeficiency history;
- according to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial;
Trial locations and contacts
1 site in 1 country.
Shusen Wang, doctor contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Shusen Wang, doctor, wangshs@mail.sysu.edu.cn
About this study
Official title: A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics
This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.
- Conditions
- Advanced Cancer
- Being tested
- Sinotecean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinoteceanDrug
| Study group | Role | What they receive |
|---|---|---|
| Sinotecean | Experimental | Not described Receives: Drug: Sinotecean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessments for Area Under Curve（AUC）
To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h
Measured: Day 1-2 Single Dose
Pharmacokinetic Assessments for Cmax
Measured: Day 1-2 Single Dose
Pharmacokinetic Assessments for Tmax
Measured: Day 1-2 Single Dose
Secondary outcomes (3)
Objective Response Rate （ORR)
Measured: each 42 days up to intolerance the toxicity or progression of disease（PD） (up to 24 months)
Maximum tolerated dose(MTD)
Measured: up to 24 months
Dose-limiting toxicity(DLT)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469883
- Sponsor's protocol ID
- XNTK-I-03
- Status last verified
- Jun 2015
- First submitted
- 22 Mar 2015
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Sinotecean on Tolerance and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT02469883
- Acronym / sponsor ID
- XNTK-I-03
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinotecean | Experimental | Drug: Sinotecean |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- late malignant tumor patients diagnosed with the pathological and/or cytological;
- lack of the standard treatment or treatment failure;
- 18-65years, ECOG:0-1,expected survival period >3 months;
- main organs function is normal;
- signed and dated informed consent
Key exclusion criteria (9 listed)
- participated in other clinical trials in four weeks;
- currently under other effective treatment;
- end of anti-tumor treatment within 4 weeks(end of Nitrosourea/Mitomycin within 6 weeks);
- AE ≥ Grade 2(according to NCI-CTC 4.0),except hair loss;
- with ischemic heart disease, heart failure, severe arrhythmia, cerebrovascular disease, asthma, severe infections, active peptic ulcer;
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 |
|---|---|---|
| Sinotecean | Drug | Sinotecean |
Primary outcome
Pharmacokinetic Assessments for Area Under Curve（AUC）
Time frame: Day 1-2 Single Dose
To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h
Pharmacokinetic Assessments for Cmax
Time frame: Day 1-2 Single Dose
Pharmacokinetic Assessments for Tmax
Time frame: Day 1-2 Single Dose
3 secondary outcomes
Objective Response Rate （ORR)
Time frame: each 42 days up to intolerance the toxicity or progression of disease（PD） (up to 24 months)
Maximum tolerated dose(MTD)
Time frame: up to 24 months
Dose-limiting toxicity(DLT)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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.
Shusen Wang, doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sinotecean in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shusen Wang, doctor (wangshs@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Assessments for Area Under Curve（AUC） (time frame: Day 1-2 Single Dose). The study lists 3 primary outcomes in all. 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 12 Jun 2015.