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MMC

Phase 3

Bladder Cancer | Small molecule | Oncology |UroGen Pharma Ltd.|Trials Updated: Jun 16, 2017

MMC development status

Highest phase Phase 3 run by Janssen Research & Development, LLC (NCT06319820)
Phase scored for URGNPhase 2
Registered trials 2 across 2 sponsors since Mar 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

MMC clinical trials

MMC · 1 trial · 4 indications

Phase 2 1
NCT02307487Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC PatientsBladder Cancer
COMPLETED14 Analytics
PHASE2COMPLETED
Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients
Bladder CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of Adverse Events (AE) findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Vital signs findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Clinical evaluation findings considered to be dose limiting according to the CTCAE V 4.0
6 weeks
Lab results considered to be dose limiting according to the CTCAE V 4.0
6 weeks

Secondary Endpoints

Rates of all adverse events or clinically relevant physical examination
15 months
Vital signs and laboratory findings
15 months
MMC maximum plasma concentration and concentration time curve during 6 hr post instillation
15 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A2EXPERIMENTAL120 mg MMC in 90ml gel
Cohort B2EXPERIMENTAL140 mg MMC in 90ml gel
Cohort C2EXPERIMENTAL160 mg MMC in 90ml gel
Cohort AEXPERIMENTAL120 mg MMC in 60ml gel
Cohort BEXPERIMENTAL140 mg MMC in 60ml gel
Cohort CEXPERIMENTAL160 mg MMC in 60ml gel

Interventions

NameTypeDescription
120 mg MMC in 90ml gelDRUG120 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
140 mg MMC in 90ml gelDRUG140 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
160 mg MMC in 90ml gelDRUG160 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
120 mg MMC in 60ml gelDRUG120 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
140 mg MMC in 60ml gelDRUG140 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
160 mg MMC in 60ml gelDRUG160 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patient is 18 years of age or older. * Patient has signed Informed Consent Form and is willing and able to abide by the protocol. * Patients diagnosed with Low Grade (LG) or High grade (HG) NMIBC. * No active urinary tract infection as confirmed by urine culture. * If the pati...

Countries:Israel
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Frequently asked questions about MMC

What is MMC in used for?

MMC in is being studied for non-muscle invasive bladder cancer (NMIBC). It is formulated as a 120 mg dose of mitomycin C in 90 mL of gel and is given intravesically, meaning directly into the bladder, before transurethral resection of bladder tumor (TURBT). It remains investigational and has not been approved for commercial use.

Who is developing MMC in?

MMC in is being developed by UroGen Pharma Ltd., which trades on the Nasdaq under the ticker URGN. The company is evaluating the drug candidate in patients with non-muscle invasive bladder cancer.

What phase is MMC in in?

MMC in is in Phase 2 clinical development. The Phase 2 trial has been completed, and the drug is not yet approved for any indication. It remains an investigational therapy.

What clinical trials is MMC in in?

MMC in has been studied in one completed Phase 2 trial, NCT02307487, titled "Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients." The trial enrolled 14 participants in Israel and evaluated the drug in bladder cancer and related urinary bladder conditions.