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

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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

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

Exclusion criteria

  • Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
  • Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
  • Has a medical history of clinically significant lung disease
  • Is suspected to have certain other protocol-defined diseases based on imaging at screening period

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:

  • safety or well-being of the participant or offspring
  • safety of study staff
  • 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

0

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Data sourced from clinicaltrials.gov

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