Trial · NCT05024773
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
NCT05024773, Phase 3, Active not recruiting, Fidia Farmaceutici s.p.a.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID). Trials, record NCT05024773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05024773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
- NCT number
- NCT05024773
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 130 participants, actual
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Conditions
- Bladder Carcinoma in Situ (CIS)
- Interventions
- ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
- First posted
- 2021-08-27
- Last updated
- 2026-06-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Centrally assessed Complete Response Rate (CRR) at any time. | CRR will be evaluated at any time from enrollment to 24 months after induction or re-induction start. | CRR calculated as the proportion of patients achieving a CR at any time within 24 months after induction or re-induction start. CRR will be based on central assessment of response |
| Secondary | Centrally assessed CRR | CRR will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction | CRR calculated as the proportion of patients achieving a CR at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction start |
| Secondary | Duration of Response (DoR) | DoR will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-inductiononths after treatment start | DoR defined as the time from first documented evidence of CR to time of documented recurrence (CIS or Ta-T1), progression to MIBC, to extravesical disease, or death |
| Secondary | Duration of Response (DoR) rate | DoR rates will be evaluated at 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 after induction or re-induction start | DoR rate calculated as the proportion of patients who maintained a CR after 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 months after induction or re-induction start. |
| Secondary | Progression rate | Progression rate will be evaluated at EOIT/EROIT, 15, 24 and 48 months after induction or re-inductionstart | Progression rate calculated as the proportion of patients with muscle invasion or extravesical expansion of the disease at EOIT/EORIT, 15, 24 and 48 months after induction or re-induction start |
| Secondary | Time to progression | Time to progression will be evaluated at 15, 24 and 48 months after induction or re-induction start | Time to progression defined as time from treatment start to time of documented tumor progression to MIBC or extravesical disease. |
| Secondary | Rate of patients undergoing cystectomy | Rate of patients undergoing cystectomy will be evaluated at EOIT/EROIT, 9, 15, 24, 24 and 48 months after induction or re-induction start. | Proportion of patients undergoing cystectomy for disease progression at EOIT/EORIT, 9, 15, 24 and 48 months after induction or re-induction start. |
| Secondary | Time to cystectomy defined as time from start of treatment to the date of cystectomy | from start of treatment to date of cystectomy | Time to cystectomy is defined as the time (months) form start of treatment to the date of cystectomy, analyzed using the Kaplan-Meier method. The median time to cystectomy will be presented along with 95% CI. |
| Secondary | event-free survival (EFS) | Event-free survival (EFS) will be evaluated at any time during the study up to 48 months after treatment start | EFS defined as time from treatment start to the time of documented recurrence after CR, or progression or death due to any cause. |
| Secondary | Overall survival (OS) | overall survival (OS) will be evaluated at any time during the study up to 48 months after treatment start | OS defined as time from treatment start to death due to any cause. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05024773
GET https://conductscience.org/api/trials/v1/NCT05024773/registered