Description:
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond
or become resistant to current treatment. DS-8201a is a new experimental product that is a
combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may
slow down tumor growth. This might improve outcomes for these patients.
Title
- Brief Title: DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
- Official Title: A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Who Are Resistant or Refractory to T-DM1
Clinical Trial IDs
- ORG STUDY ID:
DS8201-A-U201
- SECONDARY ID:
2016-004986-18
- SECONDARY ID:
JapicCTI-173693(en)
- NCT ID:
NCT03248492
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| DS-8201a | Experimental product | DS-8201a Low Dose |
Purpose
Some HER-2 breast cancer patients do not respond or build resistance to current treatment.
DS-8201a is a new experimental product that is a combination of an antibody and a drug. It
has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve
outcomes for these patients.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| DS-8201a Low Dose | Experimental | T-DM1 resistant/refractory (R/R) patients in the low dose treatment group | |
| DS-8201a Medium Dose | Experimental | T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group | |
| DS-8201a High Dose | Experimental | T-DM1 resistant/refractory (R/R) patients in the high dose treatment group | |
| Exploratory Arm | Other | In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm | |
Eligibility Criteria
Inclusion Criteria:
- Men or women the age of majority in their country
- Has pathologically documented breast cancer that:
1. is unresectable or metastatic
2. has HER2 positive expression confirmed per protocol
- Has an adequate tumor sample
- Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1
- Has protocol-defined adequate cardiac, renal and hepatic function
- Agrees to follow protocol-defined method(s) of contraception
Exclusion Criteria:
- Has a medical history of myocardial infarction, symptomatic congestive heart failure
(CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
- Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
- Has a medical history of clinically significant lung disease
- Is suspected to have certain other protocol-defined diseases based on imaging at
screening period
- Has history of any disease, metastatic condition, drug/medication use or other
condition that might, per protocol or in the opinion of the investigator, compromise:
1. safety or well-being of the participant or offspring
2. safety of study staff
3. analysis of results
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective response rate (ORR) per imaging assessment |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by independent central imaging facility review based on RECIST version 1.1 |
Secondary Outcome Measures
| Measure: | Duration of response |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | Length of time response continued |
| Measure: | Best percent change in the sum of the longest diameters (SLD) of measurable tumors |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | The best percent change from baseline in the SLD will be provided by part/dose group |
| Measure: | Disease control rate (DCR) |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | Percentage of participants with controlled disease |
| Measure: | Clinical benefit rate (CBR) |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | Percentage of participants receiving clinical benefit from the treatment |
| Measure: | Progression-free survival |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | Percentage of participants still alive without the disease getting worse |
| Measure: | Overall survival (OS) |
| Time Frame: | at 22 months |
| Safety Issue: | |
| Description: | Percentage of participants still alive |
| Measure: | ORR assessed by the investigator based on RECIST version 1.1 |
| Time Frame: | within 22 months |
| Safety Issue: | |
| Description: | Percentage of participants with objective response as assessed by the investigator, based on RECIST version 1.1 |
| Measure: | Maximum plasma/serum concentration (Cmax) |
| Time Frame: | within 21 days |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a |
| Measure: | Time to Cmax (Tmax) |
| Time Frame: | within 21 days |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a |
| Measure: | Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast) |
| Time Frame: | within 21 days |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a |
| Measure: | AUC from the time of dosing until day 21 (AUC0-21d) |
| Time Frame: | at Day 21 |
| Safety Issue: | |
| Description: | Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Daiichi Sankyo, Inc. |
Trial Keywords
- HER-2 positive breast cancer
- Metastatic or Unresectable
- Resistant or refractory to T-DM1
Last Updated
October 19, 2017
