Bladder Carcinoma in Situ (CIS)Phase 1NCT04798703
Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
A Phase 1 study testing ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) in people with Bladder Carcinoma in Situ (CIS), run by Fidia Farmaceutici s.p.a. at 5 sites in 2 countries.
Trial summary
Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant to Bacillus Calmette-Guérin (BCG)-therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Carcinoma in Situ (CIS)
- What is being tested?
- ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 24 May 2017to 18 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed CIS of the bladder. A portion of patients up to 30% could have concomitant Ta and/or T1 lesions.
- Complete resection of papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors.
- Patients were to be unresponsive or intolerant to BCG, had to have refused radical cystectomy or were not clinically suitable for cystectomy. Patients unresponsive to BCG were defined as patients for whom further BCG would be unlikely to be of benefit. This included all patients treated with an adequate course of induction plus maintenance BCG who either had persistent disease or who relapsed within 6 months of their last BCG treatment.
- Age ≥18 yrs.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Female in non-reproductive years (defined as surgically sterile or one year postmenopausal). Female of childbearing potential had to agree to practice complete abstinence or to use an effective contraceptive method.
- Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in the protocol.
- Signed and dated Independent Ethics Committee (IEC)-approved Informed Consent.
Who cannot join
- Any of the following in the previous 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart enrolled cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis.
- Known hypersensitivity to paclitaxel or any of its constituents.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment start.
- Muscle-invasive disease T2-T4.
- Previous or concomitant cancer of the upper urinary tract or the prostatic urethra.
- Prior (within the previous 3 years) or concurrent malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri.
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- Last intravesical immunotherapy dose administration <8 weeks prior to study entry. Patients had to have documentation of persistent or recurrent disease.
- Previous intravesical chemotherapy < 28 days prior to study entry with the exception of patients who underwent transurethral resection (TUR) < 7 days.
- Bladder capacity lower than 150 ml.
- Presence of significant urologic disease interfering with intravesical therapy.
- Concurrent enrollment or participation in another therapeutic clinical trial within 4 weeks preceding treatment start.
- Patients with known active substances and/or alcohol abuse.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patients inappropriate for entry into the study or, in the opinion of the Investigator and/or the Sponsor, could compromise protocol objectives.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Spain3 sites
Parc de Recerca Biomèdica de
Barcelona
Hospital Gregorio Marañón
Madrid
Hospital Universitario Fundación Alcorcón
Madrid
About this study
Official title: Phase I Exploratory Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) Administered for 12 Consecutive Weeks Followed by Maintenance Therapy in BCG Unresponsive/ Intolerant Patients With Bladder Carcinoma in Situ (CIS)
Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant to Bacillus Calmette-Guérin (BCG)-therapy.
Patients are initially treated with 12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase). Patients who achieve a complete response (CR) after the 12 weekly instillations entered the maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months.
- Conditions
- Bladder Carcinoma in Situ (CIS)
- Being tested
- ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)Drug
12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase) followed by maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months in patients who achieved a complete response (CR) after the 12 weekly instillations.
| Study group | Role | What they receive |
|---|---|---|
| ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) | Experimental | Not described Receives: Drug: ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) will be coded using MedDRA and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Overall safety profile evaluated based on clinical safety parameters (i.e. hematology and blood chemistry, urinalysis, vital signs and adverse events).
Measured: Safety data will be evaluated in the treated patient population through study completition, an average of 15 months.
Laboratory test values will be graded according to the NCI CTCAE scale, v 4.03.
For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities will be evaluated by considering the worst occurrence for each patient throughout the whole treatment period.
Measured: Safety data will be evaluated in the treated patient population through study completition, an average of 15 months.
Secondary outcomes (4)
Complete Response Rate (CRR) - End of intensive treatment phase,
Calculated as the proportion of patients who achieved a complete response after 12 weekly instillations of ONCOFID-P-B™.
Measured: CRR will be evaluated after intensive treatment phase, at 12 weeks.
CRR - End of maintenance phase
Calculated as the proportion of patients who achieved a complete response after the end of the entire treatment period (intensive + maintenance).
Measured: CRR will be evaluated after the end of the entire treatment period (intensive and maintenance), at 15 months.
CRR - At 6 months
Calculated as the proportion of patients who achieved a complete response after 6 months since treatment start.
Measured: CRR will be evaluated at 6 months since treatment start.
Rate of Overall Complete Response - Duration of Response (DoR), defined as the time from when criteria for Complete Response were first met until the first documented occurrence of CIS relapse or progression was reported.
Calculated as the proportion of patients who achieved complete response at any time during the study.
Measured: CR will be evaluated at any time during the study up to 12 months after the end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start24 May 2017
- Primary completion4 May 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Carcinoma in Situ (CIS)Studies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798703
- Sponsor's protocol ID
- R39-17-01
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Exploratory Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) Administered for 12 Consecutive Weeks Followed by Maintenance Therapy in BCG Unresponsive/ Intolerant Patients With Bladder Carcinoma in Situ (CIS)
- ClinicalTrials.gov ID
- NCT04798703
- Acronym / sponsor ID
- R39-17-01
- Conditions
- Bladder Carcinoma in Situ (CIS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 15 Mar 2021 (actual)
- 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.
Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant to Bacillus Calmette-Guérin (BCG)-therapy.
Patients are initially treated with 12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase). Patients who achieve a complete response (CR) after the 12 weekly instillations entered the maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) | Experimental | Drug: ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically confirmed CIS of the bladder. A portion of patients up to 30% could have concomitant Ta and/or T1 lesions.
- Complete resection of papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors.
- Patients were to be unresponsive or intolerant to BCG, had to have refused radical cystectomy or were not clinically suitable for cystectomy. Patients unresponsive to BCG were defined as patients for whom further BCG would be unlikely to be of benefit. This included all patients treated with an adequate course of induction plus maintenance BCG who either had persistent disease or who relapsed within 6 months of their last BCG treatment.
- Age ≥18 yrs.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (13 listed)
- Any of the following in the previous 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart enrolled cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis.
- Known hypersensitivity to paclitaxel or any of its constituents.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment start.
- Muscle-invasive disease T2-T4.
- Previous or concomitant cancer of the upper urinary tract or the prostatic urethra.
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 |
|---|---|---|
| ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase) followed by maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months in patients who achieved a complete response (CR) after the 12 weekly instillations. | Drug | ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) |
Primary outcome
Adverse events (AEs) will be coded using MedDRA and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: Safety data will be evaluated in the treated patient population through study completition, an average of 15 months.
Overall safety profile evaluated based on clinical safety parameters (i.e. hematology and blood chemistry, urinalysis, vital signs and adverse events).
Laboratory test values will be graded according to the NCI CTCAE scale, v 4.03.
Time frame: Safety data will be evaluated in the treated patient population through study completition, an average of 15 months.
For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities will be evaluated by considering the worst occurrence for each patient throughout the whole treatment period.
4 secondary outcomes
Complete Response Rate (CRR) - End of intensive treatment phase,
Time frame: CRR will be evaluated after intensive treatment phase, at 12 weeks.
CRR - End of maintenance phase
Time frame: CRR will be evaluated after the end of the entire treatment period (intensive and maintenance), at 15 months.
CRR - At 6 months
Time frame: CRR will be evaluated at 6 months since treatment start.
Rate of Overall Complete Response - Duration of Response (DoR), defined as the time from when criteria for Complete Response were first met until the first documented occurrence of CIS relapse or progression was reported.
Time frame: CR will be evaluated at any time during the study up to 12 months after the end of treatment period
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 17 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) in people with Bladder Carcinoma in Situ (CIS), run by Fidia Farmaceutici s.p.a. at 5 sites in 2 countries.
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 8 inclusion and 13 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Italy. 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?
Adverse events (AEs) will be coded using MedDRA and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. (time frame: Safety data will be evaluated in the treated patient population through study completition, an average of 15 months.). 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?
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 17 Mar 2021.