NCT01326871 · STUDY IN CONTEXT

A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose Expansion of ALT-801 in Combination With Cisplatin and Gemcitabine or ALT-801 in Combination With Gemcitabine Alone

Source null

→

primary · POSTED

Number of AEs that occur or worsen after the first dose of study treatment

Source null

→

primary · POSTED

Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.

Intent to treat population

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-transitional-cell-carcinoma
nct id: NCT01326871
trial label: A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial 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: 3
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0000
source section id
NCT01326871-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose Expansion of ALT-801 in Combination With Cisplatin and Gemcitabine or ALT-801 in Combination With Gemcitabine Alone
endpoint definition
Maximum Tolerated Dose (MTD) and/or the Recommended Dose (RD) for Dose Expansion of ALT-801 in Combination With Cisplatin and Gemcitabine or ALT-801 in Combination With Gemcitabine Alone
time origin
8 weeks
analysis role
primary
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
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0001
source section id
NCT01326871-om-0001
source outcome index
1
endpoint
Number of Participants With Adverse Events
endpoint definition
Number of AEs that occur or worsen after the first dose of study treatment
time origin
8 weeks
analysis role
primary
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
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0002
source section id
NCT01326871-om-0002
source outcome index
2
endpoint
Objective Response Rate in Treated Patients
endpoint definition
Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
time origin
12 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat population
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-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0000
arm key
OG000
arm label
ALT-801: 0.04 mg/kg, 0.06 mg/kg
regimen
Recommended dose is ALT-801 0.06 mg/kg
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0001
arm key
OG000
arm label
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
regimen
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0001
arm key
OG001
arm label
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
regimen
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0001
arm key
OG002
arm label
ALT-801 0.06 mg/kg With Gemcitabine
regimen
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0002
arm key
OG000
arm label
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
regimen
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0002
arm key
OG001
arm label
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
regimen
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
outcome key
om-0002
arm key
OG002
arm label
ALT-801 0.06 mg/kg With Gemcitabine
regimen
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01326871-om-0002#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-transitional-cell-carcinoma
nct id
NCT01326871
harm key
EG000
source section id
NCT01326871-ae
event group key
EG000
event group label
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Source null
event definition
Source null
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-transitional-cell-carcinoma
nct id
NCT01326871
harm key
EG001
source section id
NCT01326871-ae
event group key
EG001
event group label
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
serious affected
20
serious at risk
49
other affected
49
other at risk
49
frequency threshold
5
collection period
Source null
event definition
Source null
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-transitional-cell-carcinoma
nct id
NCT01326871
harm key
EG002
source section id
NCT01326871-ae
event group key
EG002
event group label
ALT-801 0.06 mg/kg With Gemcitabine
serious affected
8
serious at risk
16
other affected
16
other at risk
16
frequency threshold
5
collection period
Source null
event definition
Source null
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