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UGN-101 instillations

Phase 3

Carcinoma, Transitional Cell | Small molecule | Oncology |UroGen Pharma Ltd.|Last Updated: Dec 22, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

UGN-101 instillations · 1 trial · 2 indications

Phase 3 1
NCT02793128The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC StudyCarcinoma, Transitional Cell
COMPLETED71 Analytics
PHASE3COMPLETED
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Carcinoma, Transitional Cell
NCT0279312871
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Study Endpoints

Primary Endpoints

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 Endpoints

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
Durability of Complete Response (CR) for Each Follow-up Time Point.
3, 6, 9 and 12 months
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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UGN-101 instillationsEXPERIMENTALThe Mitomycin C (MMC) concentration of UGN-101 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.

Interventions

NameTypeDescription
UGN-101 instillationsDRUGTreatment with UGN-101 once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate complete response (CR) will be treated with UGN-101 once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Main Inclusion Criteria: 1. Patient is at least 18 years of age. 2. Naive or recurrent patients with low grade (LG), non-invasive Upper Tract Urothelial Carcinoma (UTUC) in the pyelocalyceal system. 3. Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The larg...

Countries:United StatesIsrael
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Frequently asked questions about UGN-101 instillations

What is UGN-101 instillations used for?

UGN-101 instillations is an investigational small molecule being studied for the treatment of transitional cell carcinoma, including transitional cell carcinoma of the renal pelvis. It is delivered via instillations and is currently in Phase 3 clinical development for this oncology indication.

What does UGN-101 instillations target?

UGN-101 instillations is a small molecule therapy. The specific molecular target is not disclosed in the available information. It is being evaluated for its therapeutic effect in transitional cell carcinoma through local instillations.

Who makes UGN-101 instillations?

UGN-101 instillations is being developed by UroGen Pharma Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol URGN. The company is conducting clinical trials to evaluate this investigational therapy for transitional cell carcinoma.

What phase is UGN-101 instillations in?

UGN-101 instillations is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation for transitional cell carcinoma.

What clinical trials is UGN-101 instillations in?

UGN-101 instillations has one completed Phase 3 clinical trial, the OLYMPUS Study (NCT02793128), titled 'Optimized DeLivery of Mitomycin for Primary UTUC Study.' This trial enrolled 71 participants with transitional cell carcinoma and was conducted in the United States and Israel.

Is UGN-101 instillations the same as mitomycin?

UGN-101 instillations is a formulation designed for optimized delivery of mitomycin, as indicated by the OLYMPUS Study title. However, UGN-101 instillations is a distinct investigational product being developed by UroGen Pharma for the treatment of transitional cell carcinoma.