A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer
- Conditions
- Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancerMedDRA version: 20.0Level: LLTClassification code 10010029Term: Colorectal cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003466-28-ES
- Lead Sponsor
- Daiichi Sankyo Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
- Has pathologically documented unresectable, recurrent, or metastatic
colorectal adenocarcinoma (until sponsor's notification to the study
sites, subject must be a RAS/BRAF wild-type cancer)
- Has received at least 2 prior regimens of standard treatment
- Has measurable disease assessed by the investigator based on RECIST
version 1.1.
- Has an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 to 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the objective response rate (ORR) of DS-8201a in HER2-expressing advanced metastatic colorectal cancer patients;Secondary Objective: •To evaluate duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). ORR assessed by the investigator is also evaluated.<br>•To evaluate the safety of DS-8201a<br>•To determine the pharmacokinetics (PK) of DS-8201a;Primary end point(s): Objective response rate (ORR) per imaging assessment - Percentage of participants with objective response per independent central imaging<br>facility review based on Response Evaluation Criteria In Solid Tumors<br>(RECIST) version 1.1;Timepoint(s) of evaluation of this end point: every 6 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ·Progression-free survival<br>·Overall survival<br>·Duration of response<br>·Disease control rate (DCR)<br>·ORR assessed by the investigator based on RECIST version 1.1<br>The following apply to categories; DS-8201a, total anti-HER2 antibody,<br>and MAAA-1181a<br>·Maximum serum/plasma concentration (Cmax)<br>· Time to Cmax (Tmax)<br>·Area under the concentration-time curve (AUC)<br>·AUC from the time of dosing until day 21 (AUC0-21d);Timepoint(s) of evaluation of this end point: every 6 weeks for efficacy, OS for until death or last contact with subject