DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Neoplasm, Gastrointestinal

Treatments: Drug: DS-8201a; Drug: Physician's Choice

Study type: Interventional

Funder types: Industry

Identifiers

NCT03329690

DS8201-A-J202

173727 (Registry Identifier)

DESTINY-G01 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.

Enrollment: 233 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
2. Progression on and after at least 2 prior regimens
3. Has an adequate tumor sample
4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Exclusion criteria

1. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia

2. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females

3. Has a medical history of clinically significant lung disease

4. Is suspected to have certain other protocol-defined diseases based on imaging at screening period

5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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233 participants in 4 patient groups

Parallel: DS-8201a

Experimental group

Description:

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive DS-8201a once every 3 weeks.

Treatment:

Drug: DS-8201a

Parallel: Physician's Choice

Active Comparator group

Description:

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive monotherapy prescribed by the physician before enrollment.

Treatment:

Drug: Physician's Choice

Exploratory: Naïve HER2 IHC 2+/ISH-

Other group

Description:

A maximum of 20 non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every three weeks.

Treatment:

Drug: DS-8201a

Exploratory: Naïve HER2 IHC 1+

Other group

Description:

A maximum of 20 non-randomized patients with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every 3 weeks.

Treatment:

Drug: DS-8201a