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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT02564900
• Date of registration: 21/09/2015
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo Co., Ltd.
• Public title: Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
• Scientific 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
• Date of first enrolment: September 1, 2015
• Target sample size: 292
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02564900
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan, United States

Contacts

• Name: Global Clinical Leader
• Affiliation: Daiichi Sankyo, Inc.

Key inclusion & exclusion 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:

- Satisfy at least one of the following criteria

1. 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.

2. 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)

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Solid Tumors

Intervention(s)

Drug: DS-8201a (DP2)

Drug: DS-8201a (DP1)

Drug: DS-8201a (DP)

Primary Outcome(s)

Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Secondary Outcome(s)

Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose [Time Frame: Post first dose up to Day 147]

Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Overview of Treatment-emergent Adverse Events [Time Frame: Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months]

Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose [Time Frame: Post first dose up to Day 147]

Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose [Time Frame: Post first dose up to Day 147]

Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) [Time Frame: From 6 months postdose of last participant up to 3 years 5 months]

Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose [Time Frame: Post first dose up to Day 147]

Secondary ID(s)

152978

DS8201-A-J101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca

Daiichi Sankyo, Inc.

Results

• Results available: Yes
• Date Posted: 23/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02564900