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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 : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
UroGen Pharma Ltd.

Tracking Information
First Submitted Date  ICMJE May 29, 2016
First Posted Date  ICMJE June 8, 2016
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 4, 2017
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Complete Response (CR) Rate defined as percent of patients with CR at the PDE Visit [ Time Frame: An average of 11 weeks ]
Change History Complete list of historical versions of study NCT02793128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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 *
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Official Title  ICMJE A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma
Brief Summary The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective this will lead to the development of a new treatment approach for patients suffering from Low Grade Upper Urinary Urothelial Carcinoma (UTUC).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Transitional Cell
  • Transitional Cell Carcinoma of Renal Pelvis
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: MitoGel™ instillations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 2, 2018)
71
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2016)
74
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  1. Patient is at least 18 years of age.
  2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
  3. Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15mm.
  4. Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ) showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the screening.
  5. Patient should have at least one remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm.
  6. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of HG urothelial cancer, diagnosed not more than 2 months prior to the screening.
  7. Patient with bilateral LG UTUC may be enrolled if at least one side meets the inclusion criteria for the trial and if the other kidney does not require further treatments (The other kidney can be treated prior to the beginning of the study).

Main Exclusion Criteria:

  1. Patient received BCG treatment for UC during the 6 months prior to Visit 1.
  2. The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening)
  3. Carcinoma in situ (CIS) in the past in the urinary tract.
  4. Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
  5. Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
  6. Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT02793128
Other Study ID Numbers  ICMJE TC-UT-03-P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UroGen Pharma Ltd.
Study Sponsor  ICMJE UroGen Pharma Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ifat Klein, Phd UroGen-Parma LTD
Study Chair: Seth Lerner, M.D. Baylor College of Medicine
PRS Account UroGen Pharma Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP