TriangleNCT02300610 · STUDY IN CONTEXT
Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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 enzalutamide in 21 days due to study drug related toxicity. * Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT. * Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity. * Discontinuation of a patient due to study drug related toxicity before completing cycle 1.
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).
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- trial label
- Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0000
- source section id
- NCT02300610-om-0000
- source outcome index
- 0
- endpoint
- Recommended Dose of Enzalutamide
- endpoint definition
- 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 enzalutamide in 21 days due to study drug related toxicity. * Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT. * Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity. * Discontinuation of a patient due to study drug related toxicity before completing cycle 1.
- time origin
- Up to 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants in Dose Escalation arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0001
- source section id
- NCT02300610-om-0001
- source outcome index
- 1
- endpoint
- Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)
- endpoint definition
- 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.
- time origin
- Up to 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants evaluable at time of analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0002
- source section id
- NCT02300610-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- 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).
- time origin
- 14 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All Participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0003
- source section id
- NCT02300610-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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.
- time origin
- Up to 24 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Escalation
- regimen
- Dose Escalation: Begin with Level 1 dose of enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Escalation: Level 1 Dose
- regimen
- Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Escalation: Level 2 Dose
- regimen
- Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dose Expansion
- regimen
- Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Escalation: Level 1 Dose
- regimen
- Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Escalation: Level 2 Dose
- regimen
- Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dose Expansion
- regimen
- Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Escalation: Level 1 Dose
- regimen
- Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose Escalation: Level 2 Dose
- regimen
- Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Dose Expansion
- regimen
- Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02300610-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- harm key
- EG000
- source section id
- NCT02300610-ae
- event group key
- EG000
- event group label
- Dose Escalation: Dose Level 1
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 2 years, 7 months
- event definition
- Patient deaths listed in "all cause mortality" occurred after the Adverse Event reporting period, but within the Overall Survival follow-up period.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- harm key
- EG001
- source section id
- NCT02300610-ae
- event group key
- EG001
- event group label
- Dose Escalation: Level 2 Dose
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 2 years, 7 months
- event definition
- Patient deaths listed in "all cause mortality" occurred after the Adverse Event reporting period, but within the Overall Survival follow-up period.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT02300610
- harm key
- EG002
- source section id
- NCT02300610-ae
- event group key
- EG002
- event group label
- Dose Expansion
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- 2 years, 7 months
- event definition
- Patient deaths listed in "all cause mortality" occurred after the Adverse Event reporting period, but within the Overall Survival follow-up period.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice