Trial · NCT02793128
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
NCT02793128, Phase 3, Completed, UroGen Pharma Ltd.; results first posted 2020-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study. Trials, record NCT02793128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02793128
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
- NCT number
- NCT02793128
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 71 participants, actual
- Lead sponsor
- UroGen Pharma Ltd.
- Conditions
- Carcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal Pelvis
- Interventions
- UGN-101 instillations
- First posted
- 2016-06-08
- Last updated
- 2020-12-22
- Results first posted
- 2020-11-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit). | An average of 11 weeks | The primary efficacy endpoint was the number of patients attaining complete response (CR) at the end of the treatment period (Primary Disease Evaluation (PDE) visit). The CR was defined dichotomously as "Success" if CR was confirmed at PDE visit (or relevant follow-up), and "Failure" otherwise. |
| Secondary | The Key Secondary Efficacy Endpoint Was Long-term Durability of Complete Response (CR): Number of Patients Who Maintained CR at 12 Month Post PDE Visit. This Endpoint Was Defined Only for Those Patients Who Achieved CR at the PDE Visit. | 12 months | Continuously: Duration of CR or time-to-recurrence since the Primary Disease Evaluation (PDE) Visit (i.e., time in days from the visit at which CR was determined until recurrence or censoring). This endpoint served as the main long-term durability endpoint. Dichotomously: "Success" if CR was still present at the 12 month post-PDE Visit (at Follow-Up Visit 4), and "Failure" otherwise. This endpoint served as a supportive long-term durability endpoint. |
| Secondary | Durability of Complete Response (CR) for Each Follow-up Time Point. | 3, 6, 9 and 12 months | Durability of CR defined dichotomously as "Success" if CR was achieved at Primary Disease Evaluation (PDE) visit and remained at follow-up Visit 1, Visit 2 and Visit 3 (3, 6, 9 and 12 months post PDE visit), and "Failure" otherwise. |
| Secondary | Clinical Benefit for Patients With Partial Response (PR) at the Primary Disease Evaluation (PDE) Visit. Clinical Benefit Endpoint Was Analyzed Using the Intent-to-Treat (ITT) Analysis Set, Including Patients Who Achieved Partial Response at PDE Visit. | An average of 11 weeks | Clinical benefit for patients with partial response (PR) at the PDE visit. Clinical benefit endpoint was analyzed using the Intent-to-Treat (ITT) Analysis Set, including patients who achieved partial response at PDE Visit.Partial response at PDE visit will be defined dichotomously, similarly to the primary efficacy endpoint. For subjects with partial response at PDE visit, originally planned and actual treatments will be compared. |
| Secondary | Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation of UGN-101 | Cmax: maximum plasma concentration Analysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \< 0.100 ng/mL). The mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL). The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin. |
| Secondary | Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101 | Tmax: time to maximum plasma concentration Analysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \< 0.100 ng/mL). The mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL), and the Tmax was 1.79 hours (range: 0.50 to 5.17 hours) after instillation. The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin. |
| Secondary | Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101 | Half-life (t½): terminal half-life The mean apparent t½ following instillation of mitomycin into the upper urinary tract (UUT) was 1.27 hours (76 minutes), which was longer than the true t½ of mitomycin following a 30 mg bolus injection (mean t½ value of approximately 17 minutes). The apparent t½ demonstrates that UGN-101 dissolved gradually, resulting in prolonged exposure of mitomycin following local instillation into the UUT. |
| Other | Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs). | Through study completion, an average of 15 months | Treatment-emergent AEs were most frequently reported from the Renal and urinary disorders system organ class (SOC), 59 (83.1%) patients, as expected, given the underlying indication of low grade (LG) Upper tract urothelial carcinoma (UTUC) in the study population, chemotherapeutic drug in a gel matrix instilled in the upper urinary tract (UUT), and the study procedure of treatment instillation via a ureteral catheter. The toxicity within the upper urinary tract was considered consistent with the disease under study and the mode of administration of UGN-101. Most events in the Renal and urinary disorders SOC were mild to moderate in severity and resolved. No new risks were identified and the overall safety profile was consistent with the known safety profile of endoscopic administration of intravesical mitomycin and of mitomycin. Overall, based on the safety and efficacy results to date, the benefit-risk profile of UGN-101 is favorable for the treatment of LG-UTUC. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit). | An average of 11 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Key Secondary Efficacy Endpoint Was Long-term Durability of Complete Response (CR): Number of Patients Who Maintained CR at 12 Month Post PDE Visit. This Endpoint Was Defined Only for Those Patients Who Achieved CR at the PDE Visit. | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Durability of Complete Response (CR) for Each Follow-up Time Point. | 3, 6, 9 and 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Benefit for Patients With Partial Response (PR) at the Primary Disease Evaluation (PDE) Visit. Clinical Benefit Endpoint Was Analyzed Using the Intent-to-Treat (ITT) Analysis Set, Including Patients Who Achieved Partial Response at PDE Visit. | An average of 11 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation of UGN-101 | PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs). | Through study completion, an average of 15 months | Safety: Consisted of all patients who enrolled in the study and received at least 1 instillation of UGN-101. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101 | PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters. | Hours | MEAN |
| SECONDARY | Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101 | PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters. | Hours | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit). | UGN-101 Mitomycin for Pyelocalyceal Solution | 42 | Participants | ||
The Key Secondary Efficacy Endpoint Was Long-term Durability of Complete Response (CR): Number of Patients Who Maintained CR at 12 Month Post PDE Visit. This Endpoint Was Defined Only for Those Patients Who Achieved CR at the PDE Visit. | UGN-101 Mitomycin for Pyelocalyceal Solution | 23 | Participants | ||
| Durability of Complete Response (CR) for Each Follow-up Time Point. | UGN-101 Patients Evaluated 3 Months Post PDE | 35 | Participants | ||
| Durability of Complete Response (CR) for Each Follow-up Time Point. | UGN-101 Patients Evaluated at 6 Months Post PDE | 33 | Participants | ||
| Durability of Complete Response (CR) for Each Follow-up Time Point. | UGN-101 Patients Evaluated at 9 Months Post PDE | 28 | Participants | ||
| Durability of Complete Response (CR) for Each Follow-up Time Point. | UGN-101 Patients Evaluated at 12 Months Post PDE | 23 | Participants | ||
Clinical Benefit for Patients With Partial Response (PR) at the Primary Disease Evaluation (PDE) Visit. Clinical Benefit Endpoint Was Analyzed Using the Intent-to-Treat (ITT) Analysis Set, Including Patients Who Achieved Partial Response at PDE Visit. | UGN-101 Mitomycin for Pyelocalyceal Solution | 8 | Participants | ||
| Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients. | Pharmacokinetic Population | 6.24 | Inter-Quartile Range 2.43 to 12.80 | ng/mL | |
| Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs). | UGN-101 Mitomycin for Pyelocalyceal Solution | Treatment-emergent Adverse Events (TEAEs) | 67 | Participants | |
| Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs). | UGN-101 Mitomycin for Pyelocalyceal Solution | TEAEs related to study drug | 52 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | UGN-101 Mitomycin for Pyelocalyceal Solution | 71 | |
| Overall Study | COMPLETED | UGN-101 Mitomycin for Pyelocalyceal Solution | 62 | |
| Overall Study | NOT COMPLETED | UGN-101 Mitomycin for Pyelocalyceal Solution | 9 |
Source ClinicalTrials.gov
Adverse events89
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ureteric stenosis | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 31 | 71 | 31 |
| other | Urinary tract infection | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 23 | 71 | 23 |
| other | Haematuria | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 23 | 71 | 23 |
| other | Flank Pain | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 22 | 71 | 22 |
| other | Nausea | Gastrointestinal disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 18 | 71 | 18 |
| other | Dysuria | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 16 | 71 | 16 |
| other | Renal impairment | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 14 | 71 | 14 |
| other | Vomiting | Gastrointestinal disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 14 | 71 | 14 |
| other | Abdominal Pain | Gastrointestinal disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 14 | 71 | 14 |
| other | Hydronephrosis | Renal and urinary disorders | UGN-101 Mitomycin for Pyelocalyceal Solution | 13 | 71 | 13 |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | UGN-101 Mitomycin for Pyelocalyceal Solution | 5 | 71 |
| Total, other adverse events | UGN-101 Mitomycin for Pyelocalyceal Solution | 67 | 71 |
| Total, serious adverse events | UGN-101 Mitomycin for Pyelocalyceal Solution | 28 | 71 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT02793128
GET https://conductscience.org/api/trials/v1/NCT02793128/events?page=2