Non-Invasive Papillary Carcinoma of BladderPhase 2NCT04661826
ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
A Phase 2 study testing Oncofid-P-B in people with Non-Invasive Papillary Carcinoma of Bladder, run by Fidia Farmaceutici s.p.a. at 14 sites in 3 countries.
Trial summary
The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Invasive Papillary Carcinoma of Bladder
- What is being tested?
- Oncofid-P-B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 17 May 2010to 4 Oct 2016
- Phase
- Phase 2
- 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 of both sexes aged > 18 years, women in menopause (defined as surgically sterile or one year postmenopausal);
- Cytological or histological diagnosis of bladder cancer;
- Multiple primary or recurrent Ta G1-G2 papillary cancer;
- ECOG Performance Status 0 to 1;
- Adequate bone marrow function: neutrophils ≥1.5 103/mL; platelet count ≥100 103/ mm3; Hb ≥ 10 g/dL;
- Written informed consent;
- Willing and able to comply with the protocol for the duration of the study.
Who cannot join
- Hypersensitivity to Paclitaxel or one of its constituents;
- T1 papillary cancer or muscle-invasive disease (T2-T4) ;
- Previous or concomitant tumor of the upper urinary tract, of the prostatic urethra, CIS;
- Any other malignancy diagnosed within 3 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix);
- Presence of significant urologic disease interfering with intravesical therapy;
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening or concurrent treatment with other experimental drugs;
Show all 12Show fewer
- Other chemotherapy or radiotherapy within four weeks of study entry;
- Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry;
- Bladder capacity less than 300 mL;
- Renal and hepatic function values exceeding 2 times the upper normal value;
- Severe cardiovascular diseases considered a contraindication to intravesical treatment;
- Pregnant, lactating or childbearing potential aged women.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Spain6 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Del Mar
Barcelona, 08003
Hospital del Henares
Coslada, Madrid, 28820
Hospital Clinico San Carlos
Madrid, 28040
Tenerife Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Instituto Valenciano de Oncologià
Valencia, 460009
Italy5 sites
A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
Bari, 70124
A.O. Spedali Civili di Brescia - Dipartimento di Urologia
Brescia, 25123
Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria
Pisa, 56124
Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica
Roma, 00168
A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I
Torino, 10126
Germany3 sites
Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
Essen, 45122
Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Praxisklinik Urologie Rhein-Ruhr
Mülheim, D-45468
About this study
Official title: ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY
The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
Read the detailed description
This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder.
Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.
- Being tested
- Oncofid-P-B
- Keywords
- paclitaxel, bladder cancer, hyaluronic acid
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncofid-P-BDrug
Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.
| Study group | Role | What they receive |
|---|---|---|
| Oncofid-P-B | Experimental | Oncofid-P-B will be administered once a week for 6 weeks in the first treatment phase and once a month for 6 months followed by other 6 months in the second maintenance phase Receives: Drug: Oncofid-P-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
Rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. Complete response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other sites and negative cytology.
Measured: Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7)
Secondary outcomes (3)
Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Measured: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
Number of patients with relapse within V 22.
Number of patients with relapse within V 22.
Measured: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0"
Treatment-Related Adverse Events as Assessed by CTCAE v4.0" with Oncofid-P-B given by intravesical instillation.
Measured: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start17 May 2010
- Primary completion29 Jul 2015
- Study completion4 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive Papillary Carcinoma of BladderStudies 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
- 60 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
- NCT04661826
- Sponsor's protocol ID
- R39-09-01
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY
- ClinicalTrials.gov ID
- NCT04661826
- Acronym / sponsor ID
- R39-09-01
- Keywords
- paclitaxel, bladder cancer, hyaluronic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 17 May 2010 (actual)
- Primary completion
- 29 Jul 2015 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 10 Dec 2020 (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.
The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
Detailed description
This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder.
Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.
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 | Experimental | Drug: Oncofid-P-BOncofid-P-B will be administered once a week for 6 weeks in the first treatment phase and once a month for 6 months followed by other 6 months in the second maintenance phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes aged > 18 years, women in menopause (defined as surgically sterile or one year postmenopausal);
- Cytological or histological diagnosis of bladder cancer;
- Multiple primary or recurrent Ta G1-G2 papillary cancer;
- ECOG Performance Status 0 to 1;
- Adequate bone marrow function: neutrophils ≥1.5 103/mL; platelet count ≥100 103/ mm3; Hb ≥ 10 g/dL;
Key exclusion criteria (12 listed)
- Hypersensitivity to Paclitaxel or one of its constituents;
- T1 papillary cancer or muscle-invasive disease (T2-T4) ;
- Previous or concomitant tumor of the upper urinary tract, of the prostatic urethra, CIS;
- Any other malignancy diagnosed within 3 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix);
- Presence of significant urologic disease interfering with intravesical therapy;
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-BPaclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration. | Drug | Oncofid-P-B |
Primary outcome
CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
Time frame: Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7)
Rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. Complete response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other sites and negative cytology.
3 secondary outcomes
Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Time frame: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
Number of patients with relapse within V 22.
Time frame: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0"
Time frame: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
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 10 Dec 2020.
Related trials for Non-Invasive Papillary Carcinoma of Bladder
Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
RecruitingPhase 1/2
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
RecruitingPhase 3
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
RecruitingPhase 2
A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Carcinoma, Recurrent Bladder Carcinoma
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.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncofid-P-B in people with Non-Invasive Papillary Carcinoma of Bladder, run by Fidia Farmaceutici s.p.a. at 14 sites in 3 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 7 inclusion and 12 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Italy, Germany. 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?
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?
CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor. (time frame: Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7)). 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 10 Dec 2020.