Trial · NCT02033993

Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.

NCT02033993, Phase 2, Completed, Canadian Cancer Trials Group; results first posted 2020-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen. Trials, record NCT02033993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02033993

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Trial

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

Title: Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.
NCT number: NCT02033993
Status: Completed
Phases: Phase 2
Enrollment: 199 participants, actual
Lead sponsor: Canadian Cancer Trials Group
Conditions: Urothelial Cancer
Interventions: Nab-Paclitaxel, Paclitaxel
First posted: 2014-01-13
Last updated: 2023-08-22
Results first posted: 2020-01-18

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Progression-Free Survival	42 months	PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.
Secondary	Overall Survival	42 months	Time from randomization to the date of death due to any causes, or censored at last contact date.
Secondary	Clinical Benefit Rate	42 months	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Clinical Benefit Rate = OR + SD \> 12 weeks.
Secondary	Time to Response	42 months	Time from the date of randomkization to the date of objective response according to RECIST Response Criteria was first achieved.
Secondary	Health Related Quality of Life Evaluated Using EORTC-C15-Pal	42 months	Quality of life will be assessed using the EORTC-C15-PAL questionnaire plus additional study specific questions. Changes in quality of life scores while on treatment (compared to baseline scores) will be examined using descriptive analyses and inferential statistics. The primary test to compare treatment arms will be the NCIC CTG Quality of Life Committee suggested response analyses. A change score of 10 points from baseline was defined as clinically relevant. Patients were considered improved if reported a score 10-points or better than baseline at any time point in QoL assessment. Conversely, patients were considered worsened if reported a score minus 10-points or worse than baseline at any time point in QOL assessment without the above-defined improvement being observed. Patients whose scores were between 10-point changes from baseline at every QoL assessment were considered as stable.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival	42 months	ITT population.	Months	MEDIAN
SECONDARY	Overall Survival	42 months	ITT piopulation	Months	MEDIAN
SECONDARY	Clinical Benefit Rate	42 months	ITT population	percentage of participants	NUMBER
SECONDARY	Time to Response	42 months	ITT population	Months	MEDIAN
SECONDARY	Health Related Quality of Life Evaluated Using EORTC-C15-Pal	42 months	Patients with baseline and at least 1 after treatment evaluation.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival	Arm 1		3.35	90% Confidence Interval 2.69 to 4.30	Months
Progression-Free Survival	Arm 2		3.02	90% Confidence Interval 2.14 to 4.40	Months
Overall Survival	Arm 1		7.46	90% Confidence Interval 6.44 to 8.64	Months
Overall Survival	Arm 2		8.77	90% Confidence Interval 6.11 to 10.61	Months
Clinical Benefit Rate	Arm 1		50.5	90% Confidence Interval 42.2 to 58.8	percentage of participants
Clinical Benefit Rate	Arm 2		43	90% Confidence Interval 34.9 to 51.1	percentage of participants
Time to Response	Arm 1		17.5	95% Confidence Interval 5.49 to 17.5	Months
Time to Response	Arm 2		35.8	95% Confidence Interval 0.03 to 42	Months
Health Related Quality of Life Evaluated Using EORTC-C15-Pal	Arm 1	Improved	28		Participants
Health Related Quality of Life Evaluated Using EORTC-C15-Pal	Arm 2	Improved	22		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1	99
Overall Study	STARTED	Arm 2	100
Overall Study	COMPLETED	Arm 1	96
Overall Study	COMPLETED	Arm 2	91
Overall Study	NOT COMPLETED	Arm 1	3
Overall Study	NOT COMPLETED	Arm 2	9

Source ClinicalTrials.gov

Adverse events202

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	Febrile neutropenia	Blood and lymphatic system disorders	Arm 1	7	99
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm 2	4	100
other	Hearing impaired	Ear and labyrinth disorders	Arm 1	3	99
other	Hearing impaired	Ear and labyrinth disorders	Arm 2	8	100
other	Tinnitus	Ear and labyrinth disorders	Arm 1	5	99
other	Tinnitus	Ear and labyrinth disorders	Arm 2	5	100
other	Blurred vision	Eye disorders	Arm 1	7	99
other	Blurred vision	Eye disorders	Arm 2	4	100
other	Abdominal pain	Gastrointestinal disorders	Arm 1	19	99
other	Abdominal pain	Gastrointestinal disorders	Arm 2	29	100

1 to 10 of 202Source ClinicalTrials.gov

See all 202 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1	72	99
Total, all-cause mortality	Arm 2	67	100
Total, other adverse events	Arm 1	96	99
Total, other adverse events	Arm 2	97	100
Total, serious adverse events	Arm 1	28	99
Total, serious adverse events	Arm 2	19	100

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32940628	RESULT

Source PubMed

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
Arm 1 vs Arm 2: deaths from any cause	Trial comparisons
Arm 1 vs Arm 2: 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/NCT02033993

GET https://conductscience.org/api/trials/v1/NCT02033993/events?page=2

API reference For AI assistants