Metastatic Colorectal CancerPhase 1TSB-9-W1NCT02249650
To Determine the MTD and to Evaluate the Safety, Efficacy and PK Profiles of TSB-9-W1 in Pre-treated Patients With mCRC.
A Phase 1 study testing TSB-9-W1 in people with Metastatic Colorectal Cancer, run by Taiwan Sunpan Biotechnology Development Co., Ltd. at 1 site in Taiwan.
Trial summary
TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No. 5441947) and Taiwan (Patent No. I432191 and I282280). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- TSB-9-W1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jul 2017to 25 Aug 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, age ≥ 20 years old
- Patient who is eligible and able to participate in the study and accepts to enter the study by signing written informed consent
- Patient has histologically or cytologically confirmed colorectal adenocarcinoma in stage IV under the Tumor-Node-Metastasis (TNM) staging system
- Patient must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Patient should have received at least two prior therapies for colorectal cancer (CRC) including oxaliplatin and irinotecan based regimens.
- Patient should have received at least one of the target therapies for CRC including Cetuximab, Bevacizumab, Panitumumab, Regorafenib, and Ziv-aflibercept.
Show all 31Show fewer
- Patient with primary major surgery needs to have elapsed ≥ 2 weeks prior to the planned first study treatment day
- Patient who has ever received chemotherapy, or immunotherapy, or biologic therapy modalities need to wash-out ≥ 2 weeks prior to the baseline visit
- Patient who has ever received radiotherapy (including chemoradiation therapy) need to end the course ≥ 2 weeks before baseline visit (palliative radiotherapy can be performed on non-study-related local lesions)
- Patient's life expectancy ≥ 3 months
- Within 4 weeks of planned first study treatment day, adequate hematopoietic functions are presented:
- Total white blood cell (WBC) ≥ 3,000 cells/mm3
- Absolute neutrophil count (ANC) ≥ 1,500 /mm3
- Hemoglobin (Hb) ≥ 9.0 g/dL
- Platelets ≥ 100,000 cells/mm3
- Within 4 weeks of planned first study treatment day, adequate hepatic and renal functions (AST: aspartate aminotransferase, ALT: alanine aminotransferase, ALP: alkaline phosphatase) are presented:
- Total bilirubin ≤ 2.0 mg/dL
- AST ≤ 3 x ULN; liver metastasis patients: AST ≤ 5 x ULN
- ALT ≤ 3 x ULN; liver metastasis patients: ALT ≤ 5 x ULN
- ALP ≤ 5 x ULN
- Creatinine ≤ 1.5 mg/dL
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- Patient can take food and drug orally
- Male and female patients should use appropriate contraception method(s) shown below during the study and at least 2 weeks after the end of treatment for female patients.
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
- Combination of any two of the following (a+b or a+c, or b+c):
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Who cannot join
- Patient who has participated in other investigational studies within 4 weeks prior to the first dose of the study medications
- Patient has history of another malignancy within 5 years prior to study entry, except curatively treated non-melanoma skin cancer, or cervical cancer in situ
- Patient with known or suspected hypersensitivity to TSB-9-W1 or its formulation excipients
- Patient has another severe and/or life-threatening medical disease
- Patient has immuno-compromised condition, with known autoimmune conditions or human immunodeficiency virus (HIV) seropositivity
- Patient with active systemic infections, active and clinically significant cardiac diseases, clinically active gastroduodenal ulcers, or medical conditions that may significantly affect adequate absorption of investigational product
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- Patient with known brain metastasis
- Patient with medical, social or psychological factors interfering with compliance
- Patient having grade ≥ 3 adverse event (AE) based on National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE) 4.03 except blood total bilirubin, AST, ALT, ALP and creatinine at baseline visit
- Patient having grade ≥ 1 diarrhea based on NCI-CTCAE 4.03.
- Patient with a medical history of myocardial infraction in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety, Efficacy and Pharmacokinetics Profiles of TSB-9-W1 in Pre-treated Patients With Metastatic Colorectal Cancer (mCRC).
TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.
5441947) and Taiwan (Patent No. I432191 and I282280). The R\&D laboratory in TSB is ISO/IEC 17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is 2026.The trade name of TSB-9-W1 is "IDS" in English, the registration number is 01472800 at 2011 by Intellectual Property Office (IPO), Taiwan.
Read more
A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal cancer (mCRC).
there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.
This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.
Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous 3-day rest. Patient should take the study drug once daily before meal with approximately 250 ml or appropriate amount of water.
Read the detailed description
Study Design
This study is to establish the MTD of TSB-9-W1 for mCRC patients with a traditional 3+3 dose escalation method.
Study Structure
A dose escalation scenario is designed to determine the MTD according to the DLT.
Dose escalation scale:
The dose levels of investigation product are planned to be administered for determining MTD and DLT.
Dose escalation scenario:
Patients will be enrolled in a cohort of 3 patients for each dose level. Dose escalation will proceed sequentially from the lowest dose cohort. No intra-subject dose escalation is allowed. Each patient's first dose will be at least 3-day apart from the very next patient's first dose.
DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is with NCI-CTCAE Grade of 3 and this event lasts > 3 days despite appropriate supportive cares or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as determined by the investigator to be at least possibly related in causality to the IP administration.
DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the first 3 patients experience DLT, then dose escalation will proceed for the next cohort of patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently). If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in any dose cohort, the dose escalation will be withheld and the prior dose level is considered as the MTD unless present dose level is level 1 (200 mg/day).
Data and Safety Monitoring Board (DSMB) meeting will be held to review safety data prior to each dose escalation
Cut-off criteria Enrolled patients will be treated until disease progression. This study will be ended while either condition below is confirmed.
- All patients are Disease Progression (PD) or death or loss of follow up.
- Last treated patient receives 9-month treatment.
Duration of Treatment
TSB-9-W1 in a 5-day treatment cycle until disease progression or study cut-off.
Compensation/reward information
There is no Compensation/reward for subject attend the study.
Results
Primary Endpoint:
MTD and DLTs DCR assessed by RECIST 1.1.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- TSB-9-W1
- Keywords
- metastatic colorectal cancer, TSB-9-W1
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSB-9-W1Drug
Also called TSB-9-W1(IDS)
Product name: TSB-9-W1 Unit dose: 100 mg per capsule Dosage form: Capsule Treatment cycle: A treatment cycle consists of 2-day on-dose oral administering and followed by a 3-day off-dose.
| Study group | Role | What they receive |
|---|---|---|
| TSB-9-W1 cohort | Experimental | TSB-9-W1 200 mg/day (Cohort 1) TSB-9-W1 400 mg/day (Cohort 2) TSB-9-W1 600 mg/day (Cohort 3) TSB-9-W1 800 mg/day (Cohort 4) TSB-9-W1 1000 mg/day (Cohort 5) Receives: Drug: TSB-9-W1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the first 3 patients experience DLT, then dose escalation will proceed for the next cohort of patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently). If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in any dose cohort, the dose escalation will be withheld and the prior dose level is considered as the MTD unless present dose level is level 1 (200 mg/day).
Measured: up to 3 years
Dose limiting toxicities (DLTs)
DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is with NCI-CTCAE Grade of 3 and this event lasts > 3 days despite appropriate supportive cares or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as determined by the investigator to be at least possibly related in causality to the IP administration.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start10 Jul 2017
- Primary completion12 Feb 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Sunpan Biotechnology Development Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Tsai-Sheng Yang, Bachelor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249650
- Sponsor's protocol ID
- SUNTSBA20110201
- Acronym
- TSB-9-W1
- Status last verified
- Mar 2022
- First submitted
- 4 Sep 2014
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20. doi: 10.1093/jnci/djp079. Epub 2009 May 12.
PubMed 19436029Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.
PubMed 19001325
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety, Efficacy and Pharmacokinetics Profiles of TSB-9-W1 in Pre-treated Patients With Metastatic Colorectal Cancer (mCRC).
- ClinicalTrials.gov ID
- NCT02249650
- Acronym / sponsor ID
- TSB-9-W1 / SUNTSBA20110201
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, TSB-9-W1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Taiwan Sunpan Biotechnology Development Co., Ltd.University, hospital or other
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 25 Sep 2014 (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.
TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.
5441947) and Taiwan (Patent No. I432191 and I282280). The R\&D laboratory in TSB is ISO/IEC 17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is 2026.The trade name of TSB-9-W1 is "IDS" in English, the registration number is 01472800 at 2011 by Intellectual Property Office (IPO), Taiwan.
A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal cancer (mCRC).
there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.
This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.
Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous 3-day rest. Patient should take the study drug once daily before meal with approximately 250 ml or appropriate amount of water.
Detailed description
Study Design
This study is to establish the MTD of TSB-9-W1 for mCRC patients with a traditional 3+3 dose escalation method.
Study Structure
A dose escalation scenario is designed to determine the MTD according to the DLT.
Dose escalation scale:
The dose levels of investigation product are planned to be administered for determining MTD and DLT.
Dose escalation scenario:
Patients will be enrolled in a cohort of 3 patients for each dose level. Dose escalation will proceed sequentially from the lowest dose cohort. No intra-subject dose escalation is allowed. Each patient's first dose will be at least 3-day apart from the very next patient's first dose.
DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is with NCI-CTCAE Grade of 3 and this event lasts > 3 days despite appropriate supportive cares or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as determined by the investigator to be at least possibly related in causality to the IP administration.
DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the first 3 patients experience DLT, then dose escalation will proceed for the next cohort of patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently). If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in any dose cohort, the dose escalation will be withheld and the prior dose level is considered as the MTD unless present dose level is level 1 (200 mg/day).
Data and Safety Monitoring Board (DSMB) meeting will be held to review safety data prior to each dose escalation
Cut-off criteria Enrolled patients will be treated until disease progression. This study will be ended while either condition below is confirmed.
- All patients are Disease Progression (PD) or death or loss of follow up.
- Last treated patient receives 9-month treatment.
Duration of Treatment
TSB-9-W1 in a 5-day treatment cycle until disease progression or study cut-off.
Compensation/reward information
There is no Compensation/reward for subject attend the study.
Results
Primary Endpoint:
MTD and DLTs DCR assessed by RECIST 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSB-9-W1 cohort | Experimental | Drug: TSB-9-W1TSB-9-W1 200 mg/day (Cohort 1) TSB-9-W1 400 mg/day (Cohort 2) TSB-9-W1 600 mg/day (Cohort 3) TSB-9-W1 800 mg/day (Cohort 4) TSB-9-W1 1000 mg/day (Cohort 5) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Female or male, age ≥ 20 years old
- Patient who is eligible and able to participate in the study and accepts to enter the study by signing written informed consent
- Patient has histologically or cytologically confirmed colorectal adenocarcinoma in stage IV under the Tumor-Node-Metastasis (TNM) staging system
- Patient must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Patient should have received at least two prior therapies for colorectal cancer (CRC) including oxaliplatin and irinotecan based regimens.
Key exclusion criteria (11 listed)
- Patient who has participated in other investigational studies within 4 weeks prior to the first dose of the study medications
- Patient has history of another malignancy within 5 years prior to study entry, except curatively treated non-melanoma skin cancer, or cervical cancer in situ
- Patient with known or suspected hypersensitivity to TSB-9-W1 or its formulation excipients
- Patient has another severe and/or life-threatening medical disease
- Patient has immuno-compromised condition, with known autoimmune conditions or human immunodeficiency virus (HIV) seropositivity
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 |
|---|---|---|
| TSB-9-W1Also: TSB-9-W1(IDS)Product name: TSB-9-W1 Unit dose: 100 mg per capsule Dosage form: Capsule Treatment cycle: A treatment cycle consists of 2-day on-dose oral administering and followed by a 3-day off-dose. | Drug | TSB-9-W1 cohort |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: up to 3 years
DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the first 3 patients experience DLT, then dose escalation will proceed for the next cohort of patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently). If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in any dose cohort, the dose escalation will be withheld and the prior dose level is considered as the MTD unless present dose level is level 1 (200 mg/day).
Dose limiting toxicities (DLTs)
Time frame: 30 days
DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is with NCI-CTCAE Grade of 3 and this event lasts > 3 days despite appropriate supportive cares or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as determined by the investigator to be at least possibly related in causality to the IP administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 19436029Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20. doi: 10.1093/jnci/djp079. Epub 2009 May 12.
- Background: PubMed 19001325Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.
- 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.
Tsai-Sheng Yang, Bachelor principal investigator
Chang Gung Memorial Hospital
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 TSB-9-W1 in people with Metastatic Colorectal Cancer, run by Taiwan Sunpan Biotechnology Development Co., Ltd. at 1 site 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 31 inclusion and 11 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: finished, as of the sponsor's last update on 1 Apr 2022. 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 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) (time frame: up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249650, which also lists 2 linked publications.
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 1 Apr 2022.