Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
Key facts
- Study ID
- NCT02564900
- Run by
- Daiichi Sankyo Co., Ltd.
- People needed
- 292
- Starts
- 2015-09-01
- Expected to finish
- 2023-12-22
- Last updated by the study team
- 2024-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%
- Part 1:
- Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Part 2a:
- Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Treated with ado-trastuzumab emtansine (T-DM1)
- Part 2b:
- Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Treated with trastuzumab
- Part 2c:
- Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Part 2d:
- Satisfy at least one of the following criteria
- Advanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Part 2e:
- Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)
You may not qualify if…
- Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
- Has a medical history of myocardial infarction or unstable angina.
- Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
- Has a medical history of clinically significant lung diseases
Where it is running
- Sharp Memorial Hospital — San Diego, California, United States
- Mayo Clinic — Jacksonville, Florida, United States
- University of Louisville — Louisville, Kentucky, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- UC Health Clinical Trials Office — Cincinnati, Ohio, United States
- University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States
- Aichi Cancer Center Hospital — Aichi, Japan
- National Cancer Center Hospital East — Chiba, Japan
- Social Medical Corporation Hakuaikai Sagara Hospital — Kagoshima, Japan
- Kindai University Hospital — Osaka, Japan
- National Cancer Center Hospital — Tokyo, Japan
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Tokyo, Japan
Full record on ClinicalTrials.gov
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