mitomycin has been researched along with Flatulence 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.
Flatulence: Production or presence of gas in the gastrointestinal tract which may be expelled through the anus.
| 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) |
| 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 | 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 |
| 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] | |||||||
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 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 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 |
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 |
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 |
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 |
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 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 |
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 |
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 |
1 trial available for mitomycin and Flatulence
| Article | Year |
|---|---|
Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Nonmuscle-Invasive Bladder Cancer.
Topics: Administration, Intravesical; Adult; Antibiotics, Antineoplastic; Female; Flatulence; Humans; Male; | 2022 |