Study of Poziotinib in Patients With HER2-Positive 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: NCT02659514|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Poziotinib||Phase 2|
This is a phase 2, open-label, multicenter study to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in patients with HER2-positive metastatic breast cancer who have received at least 2 prior HER2-directed treatment regimens.
Each treatment cycle will be 21 days in duration. During each 21-day cycle, patients who are eligible for participation will receive poziotinib orally once daily.
All treated patients will be followed up until disease progression, death, intolerable adverse events or up to a maximum of 24 months whichever comes earlier.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC|
|Actual Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||April 2021|
|Experimental: Poziotinib, oral tablets||
Supplied as oral tablets, administered daily for each 21 days cycle.
Other Name: HM781-36B
- Objective Response Rate [ Time Frame: 24 month ]defined as the best response [Complete Response (CR) + Partial Response (PR)] recorded from the start of the study until the end of study in patients who received at least 1 dose of poziotinib.
- Progression Free Survival (PFS) [ Time Frame: 24 Months ]
- Disease Control Rate (DCR) [ Time Frame: 24-Months ]
- Time to Progression (TTP) [ Time Frame: 24 Months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659514
|Study Director:||Shanta Chawla, MD||Spectrum Pharmaceuticals, Inc|