H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Bladder Cancer or Carcinoma, Transitional Cell. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recommended Dose of EnzalutamidePrimary· Up to 6 months
Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide.
Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT.
* 7 consecutive missed doses (out of 21 doses) of enzalutamid
Group
Value
95% CI
Dose Escalation
160
Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)Secondary· Up to 6 months
Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Group
Value
95% CI
Dose Escalation: Level 1 Dose
3.81
1.45 – 4.14
Dose Escalation: Level 2 Dose
14.63
13.71 – 15.88
Dose Expansion
7.68
6.25 – 10.03
Overall Survival (OS)Secondary· Up to 24 Months
Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population.
Group
Value
95% CI
Dose Escalation: Level 1 Dose
4.14
3.81 – 10.59
Dose Escalation: Level 2 Dose
14.63
13.71 – 22.09
Dose Expansion
10.03
6.25 – 20.05
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years, 7 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Escalation: Dose Level 1
Serious: 2/3 (67%)
Deaths: 3/3
Dose Escalation: Level 2 Dose
Serious: 3/3 (100%)
Deaths: 3/3
Dose Expansion
Serious: 3/4 (75%)
Deaths: 2/4
Serious adverse events (23 terms)
Reaction
System
Dose Escalation: Dose Leve…
Dose Escalation: Level 2 D…
Dose Expansion
Nausea
Gastrointestinal disorders
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Oral pain
Gastrointestinal disorders
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Pancreatitis
Gastrointestinal disorders
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Small intestinal obstruction
Gastrointestinal disorders
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Vomiting
Gastrointestinal disorders
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Device related infection
Infections and infestations
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Kidney infection
Infections and infestations
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Lung infection
Infections and infestations
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Sepsis
Infections and infestations
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Urinary tract infection
Infections and infestations
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Fall
Injury, poisoning and procedural complications
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Creatinine increased
Investigations
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Dehydration
Metabolism and nutrition disorders
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Hypokalemia
Metabolism and nutrition disorders
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Hyponatremia
Metabolism and nutrition disorders
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Neoplasms benign, malignant and unspecified - Other
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and cisplatin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07287150 — A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT07226986 — A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI i
· Phase 1, PHASE2
· recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
· Phase 1
· recruiting
NCT07028853 — This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide W
· Phase 3
· recruiting
NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC)
· Phase 2
· recruiting
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 1 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02300610.