Trial · NCT01625260

A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer

NCT01625260, Phase 1, Phase 2, Terminated, Altor BioScience; results first posted 2024-07-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer. Trials, record NCT01625260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01625260

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
NCT number: NCT01625260
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 12 participants, actual
Lead sponsor: Altor BioScience
Conditions: Non-muscle Invasive Bladder Cancer
Interventions: ALT-801, Gemcitabine
First posted: 2012-06-21
Last updated: 2024-07-19
Results first posted: 2024-07-19
Limitations and caveats: Gemcitabine dosing was added in version 3 of the study protocol. 2 subjects were enrolled in protocol versions 1 and 2, which is why these subjects did not receive gemcitabine.~The study was terminated early due to low enrollment.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety Profile	12 weeks	Confirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.
Primary	Disease Response Rate	From start of study treatment to up to 13 weeks	The response rate was calculated as the ratio of the number of patients who demonstrated a complete response (by RECIST v1.1) divided by the number of patients evaluable for response. A complete response was defined as having negative bladder biopsy results.
Secondary	Duration of Response	From confirmed complete response to up to 3 years	Duration of response was defined as the time from the date of first complete response (by RECIST v1.1) to the date of disease progression (by RECIST v1.1) or death (from any cause), whichever occured first. A complete response was defined as having negative bladder biopsy results. Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Secondary	Progression-free Survival	From start of study treatment to up to 3 years	The progression-free survival was defined as the time from the start of study treatment to first documentation of objective tumor progression or disease recurrence (by RECIST v1.1). Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Secondary	Event-free Survival	From start of study treatment to up to 3 years	The event-free survival was defined as the time from the start of study treatment to first documentation of objective tumor progression (by RECIST v1.1), disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to any cause, which ever came first. Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Secondary	Overall Survival	From start of study treatment to up to 3 years	OS was defined as the time from start of study treatment to death resulting from any cause.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety Profile	12 weeks		Number of DLTs	NUMBER
PRIMARY	Disease Response Rate	From start of study treatment to up to 13 weeks	The population only included patients evaluable for response. 2 participants had no disease response information provided.	percentage of participants	NUMBER
SECONDARY	Duration of Response	From confirmed complete response to up to 3 years	Subjects with complete response	Months	MEDIAN
SECONDARY	Progression-free Survival	From start of study treatment to up to 3 years	The population only included patients evaluable for response. 2 participants had no disease response information provided.	Months	MEDIAN
SECONDARY	Event-free Survival	From start of study treatment to up to 3 years	The population only included patients evaluable for response. 2 participants had no disease response information provided.	Months	MEDIAN
SECONDARY	Overall Survival	From start of study treatment to up to 3 years		Months	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Safety Profile	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2		Number of DLTs
Safety Profile	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	1		Number of DLTs
Disease Response Rate	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	43	95% Confidence Interval 9.9 to 81.6	percentage of participants
Disease Response Rate	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	67	95% Confidence Interval 9.4 to 99.2	percentage of participants
Duration of Response	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	NA	95% Confidence Interval 5.2 to NA	Months
Duration of Response	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2.1	95% Confidence Interval 1.2 to NA	Months
Progression-free Survival	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3.4	95% Confidence Interval 1.7 to NA	Months
Progression-free Survival	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2.9	95% Confidence Interval 2.7 to NA	Months
Event-free Survival	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3.4	95% Confidence Interval 1.7 to NA	Months
Event-free Survival	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2.9	95% Confidence Interval 2.7 to NA	Months

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	9
Overall Study	STARTED	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3
Overall Study	COMPLETED	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2
Overall Study	COMPLETED	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2
Overall Study	NOT COMPLETED	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	7
Overall Study	NOT COMPLETED	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	1

Source ClinicalTrials.gov

Adverse events166

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Chills	General disorders	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	7	9
other	Chills	General disorders	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2	3
other	Fatigue	General disorders	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	6	9
other	Fatigue	General disorders	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2	3
other	Edema limbs	General disorders	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	4	9
other	Edema limbs	General disorders	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2	3
other	Fever	General disorders	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3	9
other	Fever	General disorders	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2	3
other	Dry skin	General disorders	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	1	9
other	Dry skin	General disorders	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	0	3

1 to 10 of 166Source ClinicalTrials.gov

See all 166 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	2	9
Total, all-cause mortality	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	1	3
Total, other adverse events	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	9	9
Total, other adverse events	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3	3
Total, serious adverse events	0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	3	9
Total, serious adverse events	0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine	1	3

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine vs 0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine: deaths from any cause	Trial comparisons
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine vs 0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01625260

GET https://conductscience.org/api/trials/v1/NCT01625260/events?page=2

API reference For AI assistants