Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer
|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: NCT02594371|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2015
Last Update Posted : May 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Oraxol Drug: IV paclitaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized, Multicenter, Phase 3 Study to Determine the Safety, Tolerability, and Tumor Response of Oraxol and Its Comparability to IV Taxol or Generic IV Paclitaxel in Subjects With Metastatic Breast Cancer|
|Actual Study Start Date :||December 2, 2015|
|Actual Primary Completion Date :||July 25, 2019|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Oraxol (paclitaxel + HM30181AK-US)
Oraxol paclitaxel - supplied as 30-mg capsules
Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets
Active Comparator: IV paclitaxel
IV paclitaxel - supplied as Taxol or generic
Drug: IV paclitaxel
- Tumor response as determined by response criteria [ Time Frame: 19 to 22 weeks ]Tumor response is evaluated using the response evaluation criteria in solid tumors (RECIST v1.1 criteria).
- Safety and tolerability assessments of Oraxol compared with IV paclitaxel, as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to ~48 months (expected end of study).] ]Safety assessments will consist of determining and recording all AEs and SAEs; laboratory evaluation of hematology, blood chemistry, and urine analyses; periodic measurement of vital signs and electrocardiograms (ECGs); and the performance of physical examinations, as detailed in the schedule of procedures and assessments of the protocol
- Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to ~48 months (expected end of study). ]The endpoint of progression-free survival is defined as not having died or progression of disease. Lost to follow-up will be considered as censored.
- Overall survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to ~48 months (expected end of study). ]The endpoint of overall survival is defined as death, confirmed alive, and lost to follow-up. Alive and lost to follow-up will be considered as censored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594371
|Study Director:||David Cutler, MD||Kinex Pharmaceuticals Inc.|