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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT02564900
First received: September 21, 2015
Last updated: April 27, 2017
Last verified: April 2017
  Purpose
This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.

Condition Intervention Phase
Advanced Solid Tumors Drug: DS-8201a Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: Day 1 through 28 days after last dose ]
    frequency and seriousness of treatment emergent adverse events (TEAEs).

  • Tumor response using RECIST version 1.1 throughout study [ Time Frame: from randomization date until disease progresses, whichever comes first, up to 30 months ]
    RECIST = Response Evaluation Criteria In Solid Tumors Assessment of tumor response is conducted every 6 weeks in the first 24 weeks and thereafter every 12 weeks until progressive disease to evaluate the efficacy of DS-8201a up to 30 months.


Secondary Outcome Measures:
  • Change in the area under curve AUC of DS-8201a [ Time Frame: from first dose to Day 45 ]
    area under curve AUC at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.

  • Change in the maximum plasma concentration Cmax of DS-8201a [ Time Frame: from first dose to Day 45 ]
    maximum plasma concentration Cmax at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.

  • Change in the time of maximum plasma concentration Tmax of DS-8201a [ Time Frame: from first dose to Day 45 ]
    time of maximum plasma concentration Tmax at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.

  • Change in the total anti-HER2 antibody [ Time Frame: from first dose to Day 45 ]
    Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.

  • Change in MAAA-1181 level [ Time Frame: from first dose to Day 45 ]
    determine the change in MAAA-1181 level from first dose to Day 45 at Cycle 1, Days 1, 2, 4, 8, 15; Cycles 2, 4, 6, and 8, Day 1; Cycle 3, Days 1, 8, 15.


Estimated Enrollment: 198
Study Start Date: August 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Dose escalation
Part 1 is a dose escalation to identify the Maximum Tolerated dose (MTD) or the recommended phase 2 dose of DS-8201a guided by the modified continuous reassessment method using a Baysian logistic regression model following escalation with overdose control principal.
Drug: DS-8201a
Experimental: Part 2 Dose expansion
Part 2 is a dose expansion to examine the safety and efficacy of DS-8201a and it is consist of multiple cohorts: in subjects with trastuzumab emtansine (T-DM1)-treated HER2 overexpressing breast cancer (Part 2a); trastuzumab-treated HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Part 2b); HER2 low expressing breast cancer (Part 2c), and HER2 expressing other solid malignant tumor (Part 2d)
Drug: DS-8201a

Detailed Description:
This study is one single group of participants in two periods. It is therefore not randomized. The dosage strength will change during the study but all participants will receive the same study drug DS-8201a. So the study is not a true 2 arm study, it is a 2 part study.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  • Advanced 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02564900

Contacts
Contact: Yoshihiko Fujisaki, DL +81-3-3492-3131

Locations
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Ohio
UC Health Clinical Trials Office Not yet recruiting
Cincinnati, Ohio, United States, 45229
United States, Texas
University of Texas M. D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030-3721
Japan
Aichi Cancer Center Hospital Recruiting
Aichi-ken, Japan
National Cancer Center Hospital East Recruiting
Chiba-ken, Japan
Kindai University Hospital Recruiting
Osaka-fu, Japan
National Cancer Center Hospital Recruiting
Tokyo-to, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research Recruiting
Tokyo-to, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02564900     History of Changes
Other Study ID Numbers: DS8201-A-J101
Study First Received: September 21, 2015
Last Updated: April 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Advanced solid tumors
phase 1
oncology
HER2
Antibody drug conjugate (ADC)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 16, 2017