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

Daiichi Sankyo logo

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)

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

Trial documents
1

Trial contacts and locations

66

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Data sourced from clinicaltrials.gov

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