A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03429101|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Poziotinib Drug: T-DM1||Phase 1|
In Part 1, the dose of poziotinib, in combination with the standard dose of T-DM1 (3.6 mg/kg IV) on Day 1 of each cycle will be determined using a "3+3" design with up to 3 dose levels tested beginning with 8 mg/day.
Poziotinib dose escalation/de-escalation for the next dose cohort will proceed based on the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of the dose cohort. Patients in the dose cohort, if not discontinued, will continue treatment until discontinuation.
In Part 2 of the study, approximately 10 patients will be treated at the MTD/MAD to confirm dose for safety of the combination and to evaluate preliminary efficacy. Treatment for all patients will continue until disease progression, unacceptable toxicity, or continuation of study treatment is not in the best interest of the patient.
The Screening period (Day -30 to Day -1) will last up to 30 days prior to Cycle 1, Day 1.
During each 21-day cycle, eligible patients will receive poziotinib at the assigned dose, orally, once daily. T-DM1 3.6 mg/kg IV will be administered on Day 1 of each treatment cycle.
All treated patients will be followed for response until disease progression or the start of new treatment and then for survival (3 year study duration).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of Poziotinib in Combination With T-DM1 in Women With Advanced or Metastatic HER2-Positive Breast Cancer|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||June 15, 2021|
Poziotinib is a tablet for oral administration.
T-DM1 (ado-trastuzumab emtansine) is a HER2-targeted therapy for I.V. administration.
Other Name: ado-trastuzumab emtansine
- Objective Response Rate (ORR) [ Time Frame: 3 Years ]Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.
- Disease Control Rate (DCR) [ Time Frame: 27 weeks ]Evaluate the Disease Control Rate (DCR) at 9, 18, and 27 weeks in patients treated at the MTD/MAD.
- Progression-free Survival (PFS) [ Time Frame: 3 years ]Evaluate Progression-free Survival (PFS) in patients treated with MTD/MAD.
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): NCT03429101
|United States, California|
|Pacific Cancer Medical Center, Inc.|
|Anaheim, California, United States, 92801|