Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02033993 |
Recruitment Status :
Completed
First Posted : January 13, 2014
Results First Posted : January 18, 2020
Last Update Posted : August 22, 2023
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | January 9, 2014 | ||||
First Posted Date ICMJE | January 13, 2014 | ||||
Results First Submitted Date ICMJE | February 21, 2019 | ||||
Results First Posted Date ICMJE | January 18, 2020 | ||||
Last Update Posted Date | August 22, 2023 | ||||
Actual Study Start Date ICMJE | March 11, 2014 | ||||
Actual Primary Completion Date | May 3, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression-Free Survival [ Time Frame: 42 months ] PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen. | ||||
Official Title ICMJE | A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen. | ||||
Brief Summary | The purpose of this study is to compare the effects on urothelial cancer of nab-paclitaxel compared to paclitaxel to treat this disease. This research is being done because currently there is no effective treatment for urothelial cancer that has progressed after prior chemotherapy. |
||||
Detailed Description | Nab-paclitaxel is a formulation of the chemotherapeutic drug paclitaxel that is combined with a human protein called albumin. In Canada, nab-paclitaxel is currently approved for the treatment of metastatic breast cancer. This drug has been tested in other cancers and has shown promising activity in lung cancer, melanoma and pancreatic cancer. Information from research studies suggests that nab-paclitaxel may be a useful treatment for urothelial cancer. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Urothelial Cancer | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Sridhar SS, Blais N, Tran B, Reaume MN, North SA, Stockler MR, Chi KN, Fleshner NE, Liu G, Robinson JW, Mukherjee SD, Rahim Y, Winquist E, Booth CM, Nguyen NT, Beardsley EK, Alimohamed NS, McDonald GT, Ding K, Parulekar WR. Efficacy and Safety of nab-Paclitaxel vs Paclitaxel on Survival in Patients With Platinum-Refractory Metastatic Urothelial Cancer: The Canadian Cancer Trials Group BL.12 Randomized Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):1751-1758. doi: 10.1001/jamaoncol.2020.3927. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
199 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | October 28, 2020 | ||||
Actual Primary Completion Date | May 3, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Note: Mixed histologies (except small cell) permitted if predominately TCC by IHC.
Exclusion Criteria:
Patients do not need CT/MRI scans to rule out brain metastases unless there is a clinical suspicion of CNS metastases.
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02033993 | ||||
Other Study ID Numbers ICMJE | BL12 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Canadian Cancer Trials Group | ||||
Original Responsible Party | NCIC Clinical Trials Group | ||||
Current Study Sponsor ICMJE | Canadian Cancer Trials Group | ||||
Original Study Sponsor ICMJE | NCIC Clinical Trials Group | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
PRS Account | Canadian Cancer Trials Group | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |