TriangleNCT02793128 · STUDY IN CONTEXT
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- trial label
- The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0005
- source section id
- NCT02793128-om-0005
- source outcome index
- 5
- endpoint
- Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
- endpoint definition
- 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.
- time origin
- Through study completion, an average of 15 months
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety: Consisted of all patients who enrolled in the study and received at least 1 instillation of UGN-101.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0000
- source section id
- NCT02793128-om-0000
- source outcome index
- 0
- endpoint
- The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit).
- endpoint definition
- 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.
- time origin
- An average of 11 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0001
- source section id
- NCT02793128-om-0001
- source outcome index
- 1
- endpoint
- 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.
- endpoint definition
- 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.
- time origin
- 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0002
- source section id
- NCT02793128-om-0002
- source outcome index
- 2
- endpoint
- Durability of Complete Response (CR) for Each Follow-up Time Point.
- endpoint definition
- 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.
- time origin
- 3, 6, 9 and 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0003
- source section id
- NCT02793128-om-0003
- source outcome index
- 3
- endpoint
- 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.
- endpoint definition
- 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.
- time origin
- An average of 11 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0004
- source section id
- NCT02793128-om-0004
- source outcome index
- 4
- endpoint
- Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
- endpoint definition
- 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.
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0000
- arm key
- OG000
- arm label
- UGN-101 Mitomycin for Pyelocalyceal Solution
- regimen
- This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
- analyzed count
- 71
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0001
- arm key
- OG000
- arm label
- UGN-101 Mitomycin for Pyelocalyceal Solution
- regimen
- Population was analyzed at 12 months post Primary Disease Evaluation (PDE) visit. 8 out of 41 patients had disease recurrence. The Kaplan-Meier estimate of 12 month duration of complete response (CR) rate was 82%. This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT). Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible patients with confirmed low grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0002
- arm key
- OG000
- arm label
- UGN-101 Patients Evaluated 3 Months Post PDE
- regimen
- Patients reaching CR at PDE evaluated at 3 months post PDE
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0002
- arm key
- OG001
- arm label
- UGN-101 Patients Evaluated at 6 Months Post PDE
- regimen
- Patients reaching CR at PDE evaluated at 6 months post PDE
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0002
- arm key
- OG002
- arm label
- UGN-101 Patients Evaluated at 9 Months Post PDE
- regimen
- Patients reaching CR at PDE evaluated at 9 months post PDE
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0002
- arm key
- OG003
- arm label
- UGN-101 Patients Evaluated at 12 Months Post PDE
- regimen
- Patients reaching CR at PDE evaluated at 12 months post PDE
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0003
- arm key
- OG000
- arm label
- UGN-101 Mitomycin for Pyelocalyceal Solution
- regimen
- This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen.
- analyzed count
- 71
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pharmacokinetic Population
- regimen
- The PK profiles of the first UGN-101 instillation in the blood were to be examined for the first 6 patients.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- outcome key
- om-0005
- arm key
- OG000
- arm label
- UGN-101 Mitomycin for Pyelocalyceal Solution
- regimen
- This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT). Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible patients with confirmed low grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen.
- analyzed count
- 71
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793128-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-transitional-cell-carcinoma
- nct id
- NCT02793128
- harm key
- EG000
- source section id
- NCT02793128-ae
- event group key
- EG000
- event group label
- UGN-101 Mitomycin for Pyelocalyceal Solution
- serious affected
- 28
- serious at risk
- 71
- other affected
- 67
- other at risk
- 71
- frequency threshold
- 5
- collection period
- The study period for Adverse Events (AEs) collection was defined from the Informed Consent Form (ICF) signature and up to 30 days following the last administration of investigational product unless the AE was suspected to be related to the study treatment or was a Serious Adverse Event, in such case the AE should be reported regardless to the timelines of the reporting period. Through study completion, an average of 15 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice