The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study (Olympus)
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|ClinicalTrials.gov Identifier: NCT02793128|
Recruitment Status : Active, not recruiting
First Posted : June 8, 2016
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Transitional Cell Transitional Cell Carcinoma of Renal Pelvis||Drug: MitoGel™ instillations||Phase 3|
Trial TC-UT-03 is a prospective, open label, single-arm trial, designed to assess the efficacy, safety, and tolerability of treatment with MitoGel™ instilled in the upper urinary system of patients with non-invasive low-grade (LG), UTUC.
Upon signing of informed consent, the patients will undergo a screening visit for eligibility evaluation. Eligible patients will be treated with MitoGel™ once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate CR will be treated with MitoGel™ once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
Five (5) weeks (± 1 w) following the last instillation, the PDE Visit, during which safety and efficacy will be assessed, will take place. During this visit, the ablative effect of the MitoGel™ will be assessed visually, by upper tract washed urine cytology, and if there are remaining tumors, by biopsy or brush biopsy if technically feasible.
Patient demonstrating CR at PDE will undergo monthly maintenance instillations of MitoGel™ up to 11 months post PDE. Safety follow-up for these patients will be done until one month post last instillation or at the end of the follow-up period in FU visit 12, which is the earlier.
For patients who did not demonstrate Complete Response, to the extent that it is possible, all remaining tumors lesions will be biopsied. The patients shall undergo any additional surgical or other treatment the PI decides deem necessary to remove remaining tumor.
An independent Data Monitoring Committee (DMC) was assigned to this trial. Accumulating safety, tolerability and efficacy data will be monitored periodically by the DMC according to a pre-specified process and frequency detailed in the DMC charter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma|
|Actual Study Start Date :||April 4, 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: MitoGel™ instillations
The MMC concentration of MitoGel™ to be used in this trial will be 4 mg MMC per 1 mL of TC-3 gel, maximum dose is 15ml. 6 once weekly intravesical instillations for the ablation treatment.
Drug: MitoGel™ instillations
Treatment with MitoGel™ once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate CR will be treated with MitoGel™ once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
Other Name: MitoGel
- Complete Response (CR) Rate defined as percent of patients with CR at the Primary Disease Evaluation (PDE) Visit [ Time Frame: An average of 11 weeks ]Complete Response (CR) Rate defined as percent of patients with CR at the Primary Disease Evaluation (PDE) Visit
- Adverse events rate [ Time Frame: 2 years ]Frequency (number of events) and incidence (number of patients) of adverse events
- Long Term Durability of Complete Response (CR) [ Time Frame: 12 months ]This endpoint is defined only for those patients demonstrating CR at PDE visit. The endpoint is defined dichotomously as "Success" if CR was obtained at follow-up Visit 4 (12 months post PDE visit), and "Failure" otherwise.
- CR rate at 3, 6 and 9 month after the PDE. [ Time Frame: 3, 6 and 9 month ]Durability of CR defined dichotomously as "Success" if CR was achieved at PDE visit and remained at follow-up Visit 1, Visit 2 and Visit 3 (3, 6 and 9 months post PDE visit), and "Failure" otherwise.
- Partial response (PR) to treatment [ Time Frame: An average of 11 weeks ]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.
- MMC level in the plasma for sub-group of patients (n=6) [ Time Frame: 1 year ]Pharmacokinetic (PK) parameter of Maximum plasma concentration [cmax]
- MMC level in the plasma for sub-group of patients (n=6) [ Time Frame: 1 year ]Pharmacokinetic (PK) parameter of Area under the Curve [AUC] Pharmacokinetic parameter of cmax of MitoGel™ in the blood of a subset of patients *
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793128
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|Study Director:||Ifat Klein, Phd||UroGen-Parma LTD|
|Study Chair:||Seth Lerner, M.D.||Baylor College of Medicine|