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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 : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
UroGen Pharma Ltd.

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Transitional Cell Carcinoma of Renal Pelvis Drug: MitoGel™ instillations Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Adverse events rate [ Time Frame: 2 years ]
    Frequency (number of events) and incidence (number of patients) of adverse events


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. MMC level in the plasma for sub-group of patients (n=6) [ Time Frame: 1 year ]
    Pharmacokinetic (PK) parameter of Maximum plasma concentration [cmax]

  5. 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 *



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


  Show 24 Study Locations
Sponsors and Collaborators
UroGen Pharma Ltd.
Investigators
Study Director: Ifat Klein, Phd UroGen-Parma LTD
Study Chair: Seth Lerner, M.D. Baylor College of Medicine

Responsible Party: UroGen Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02793128     History of Changes
Other Study ID Numbers: TC-UT-03-P
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UroGen Pharma Ltd.:
UTUC
TC-3
Mitogel
Ureteral
Upper Tract
Carcinoma
Kidney
Renal
Gel
Local
Mitomycin C
Prolonged Release
Slow Release
Kidney Sparing
T1
T0
Low Grade
Transitional Cell Carcinoma of Renal Pelvis
TCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors