Page last updated: 2024-11-06
mitomycin and Flatus
mitomycin has been researched along with Flatus in 1 studies
Mitomycin: An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.
mitomycin : A family of aziridine-containing natural products isolated from Streptomyces caespitosus or Streptomyces lavendulae.
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "Optima II ("OPTimized Instillation of Mitomycin for Bladder Cancer Treatment," clinicaltrials." | 5.51 | Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Nonmuscle-Invasive Bladder Cancer. ( Basak, R; Giannone, K; Hilton, A; Lipman, R; Mueller, D; Smith, AB; Stover, AM; Teal, R; Waheed, M, 2022) |
Research
Studies (1)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 0 (0.00) | 24.3611 |
| 2020's | 1 (100.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Stover, AM | 1 |
| Basak, R | 1 |
| Mueller, D | 1 |
| Lipman, R | 1 |
| Teal, R | 1 |
| Hilton, A | 1 |
| Giannone, K | 1 |
| Waheed, M | 1 |
| Smith, AB | 1 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence[NCT03558503] | Phase 2 | 63 participants (Actual) | Interventional | 2018-10-15 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Complete Response (CR) Rate for UGN-102 Treatment
To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC. CR rate was defined as the percentage of patients with no detectable disease (NDD) as determined by cystoscopy, for cause biopsy, and urine cytology. (NCT03558503)
Timeframe: 3 months after the first instillation of UGN-102
| Intervention | percentage of patients (Number) |
|---|
| UGN-102 | 65.1 |
Mitomycin Area Under the Plasma Concentration-time Curve (AUC)
Mitomycin AUC was assessed in a subset of 6 patients treated with UGN-102 (NCT03558503)
Timeframe: 0 (pre-instillation) to 6 hours after the first instillation of UGN-102
| Intervention | ng*h/mL (Mean) |
|---|
| UGN-102 | 5.69 |
Mitomycin Maximum Plasma Concentration (Cmax)
Mitomycin Cmax was assessed in a subset of 6 patients treated with UGN-102 (NCT03558503)
Timeframe: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102
| Intervention | ng/mL (Mean) |
|---|
| UGN-102 | 2.27 |
Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings
The number of patients with abnormal, CS physical examination findings post-baseline will be summarized (NCT03558503)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| UGN-102 | 0 |
Number of Participants With Post-baseline CS Urology-oriented Physical Examination Findings
The number of patients with abnormal, CS urology-oriented physical examination findings post-baseline will be summarized (NCT03558503)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| UGN-102 | 2 |
Number of Participants With Post-baseline PCS Vital Signs Values
The number of patients who met PCS criteria for vital signs parameters post-baseline will be summarized (NCT03558503)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| UGN-102 | 8 |
Durable Complete Response (DCR) Rate
To evaluate the durability of response in patients with LG NMIBC who achieve CR. DCR rate was defined as the percentage of patients who maintained CR at the respective time point. (NCT03558503)
Timeframe: 6, 9, and 12 months after the first instillation of UGN-102
| Intervention | percentage of patients (Number) |
|---|
| 6 months (3 months after CR at the 3-month Visit) | 9 months (6 months after CR at the 3-month Visit) | 12 months (9 months after CR at the 3-month Visit) |
|---|
| UGN-102 | 95.1 | 73.2 | 61.0 |
Mitomycin Plasma Concentrations
Mitomycin plasma concentrations were assessed in a subset of 6 patients treated with UGN-102 (NCT03558503)
Timeframe: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102
| Intervention | ng/mL (Mean) |
|---|
| Pre-instillation | 0.5 hours post-instillation | 1 hour post-instillation | 2 hours post-instillation | 3 hours post-instillation | 4 hours post-instillation | 5 hours post-instillation | 6 hours post-instillation |
|---|
| UGN-102 | 0 | 0.75 | 0.60 | 0.34 | 1.88 | 1.93 | 0.57 | 0.32 |
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values
The number of patients who met PCS criteria for chemistry or hematology parameters post-baseline will be summarized (NCT03558503)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Any PCS chemistry value | Any PCS hematology value |
|---|
| UGN-102 | 8 | 4 |
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Study Drug or Procedure Related TEAEs, TEAEs by Maximum Severity, TEAEs Leading to Treatment Discontinuation, and Serious TEAEs.
The number of patients with each type of event will be summarized. Adverse event severity was graded according to Common Terminology Criteria for Adverse Events version 5.0 as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant), Grade 4 (life-threatening), Grade 5 (fatal). (NCT03558503)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAEs | Any study drug or procedure related TEAEs | Maximum severity Grade 1 | Maximum severity Grade 2 | Maximum severity Grade 3 | Maximum severity Grade 4 | Maximum severity Grade 5 | Any TEAEs leading to treatment discontinuation | Any serious TEAEs |
|---|
| UGN-102 | 57 | 40 | 26 | 24 | 5 | 1 | 1 | 6 | 5 |
Trials
1 trial available for mitomycin and Flatus