Non Muscle Invasive Bladder CancerPhase 3NCT02982395
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
A Phase 3 study testing Nanoxel®M and Mitomycin-C in people with Non Muscle Invasive Bladder Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- Nanoxel®M and Mitomycin-C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Aug 2018
- Phase
- Phase 3
- 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
- Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)
- Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)
- No previous intravesical therapy for 6 weeks
- No history of prior radiation to the pelvis
- Peripheral neuropathy ≤ grade 1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2
- Adequate hematopoietic and hepatic parameters
Who cannot join
- Muscle invasive disease (T2-T4)
- Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)
- Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry
- History of sensitivity reaction to docetaxel
- Prescribed immunosuppressive medications because of a confounding medical condition
- Female patients who were pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- Nanoxel®M, Mitomycin-C
- Keywords
- Nanoxel M, Docetaxel PM, Docetaxel, Mitomycin C, BCG, BCG refractory, Non muscle invasive bladder cancer, intravesical, superficial bladder cancer, Urothelial carcinoma, Transitional cell carcinoma
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoxel®MDrug
Also called Polysorbate 80, ethanol free Docetaxel
Intravesical
Mitomycin-CDrug
Intravesical
| Study group | Role | What they receive |
|---|---|---|
| Nanoxel®M | Experimental | 75 mg in 100mL normal saline Receives: Drug: Nanoxel®M |
| Mitomycin | Active comparator | 40 mg in 100mL normal saline Receives: Drug: Mitomycin-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free rate
Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
Measured: 1 year
Secondary outcomes (3)
Recurrence free rate
Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy.Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
Measured: 6 months, 2 years
Overall survival
Time from random assignment to death resulting from any cause.
Measured: 2 years
Number of participants with adverse events as assessed by CTCAE v4.0
Adverse event (AE) is as any AE occurring or worsening from the first treatment of any study drug to the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ja Hyeon Ku, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982395
- Sponsor's protocol ID
- DPMBLC301
- Status last verified
- Aug 2019
- First submitted
- 24 Nov 2016
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02982395
- Acronym / sponsor ID
- DPMBLC301
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- Nanoxel M, Docetaxel PM, Docetaxel, Mitomycin C, BCG, BCG refractory, Non muscle invasive bladder cancer, intravesical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Dec 2016 (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.
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanoxel®M | Experimental | Drug: Nanoxel®M75 mg in 100mL normal saline |
| Mitomycin | Active comparator | Drug: Mitomycin-C40 mg in 100mL normal saline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)
- Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)
- No previous intravesical therapy for 6 weeks
- No history of prior radiation to the pelvis
- Peripheral neuropathy ≤ grade 1
Key exclusion criteria (6 listed)
- Muscle invasive disease (T2-T4)
- Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)
- Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry
- History of sensitivity reaction to docetaxel
- Prescribed immunosuppressive medications because of a confounding medical condition
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 |
|---|---|---|
| Nanoxel®MAlso: Polysorbate 80, ethanol free DocetaxelIntravesical | Drug | Nanoxel®M |
| Mitomycin-CIntravesical | Drug | Mitomycin |
Primary outcome
Recurrence free rate
Time frame: 1 year
Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
3 secondary outcomes
Recurrence free rate
Time frame: 6 months, 2 years
Overall survival
Time frame: 2 years
Number of participants with adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- 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.
Ja Hyeon Ku principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nanoxel®M and Mitomycin-C in people with Non Muscle Invasive Bladder Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
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 7 inclusion and 6 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 30 Aug 2019. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Recurrence free rate (time frame: 1 year). 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 30 Aug 2019.