Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01084330

Enrollment

Registered

2010-03-10

Start date

2010-04-30

Completion date

2012-05-31

Last updated

2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Cancer, Gastro-esophageal Junction Cancer

Keywords

gastric cancer, metastatic gastric cancer, advanced gastric cancer

Brief summary

A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.

Interventions

DRUGAUY922

70mg/m2

DRUGDocetaxel

Docetaxel 75mg/m2

DRUGIrinotecan

Iriniotecan 350mg/m2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Radiologically confirmed advanced gastric cancer * One previous line of chemotherapy * Progressive disease * One measurable lesion * Blood tests within protocol ranges * (WHO) Performance Status ≤ 1 * Able to sign informed consent

Exclusion criteria

* No symptomatic brain metastases * No coumarin type anticoagulants * No liver or kidney disease * No impaired heart function * No pregnant or lactating women Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	21 day cycle: treatment until death, lost to follow up or withdrawal

Secondary

Measure	Time frame
Estimate of the Overall Survival Treatment Effect to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.	21 day cycle: treatment until death, lost to follow up or withdrawal
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.	21 day cycle: treatment until death, lost to follow up or withdrawal
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922	21 day cycle: treatment until death, lost to follow up or withdrawal

Countries

Australia, Canada, France, Germany, Italy, Netherlands, Russia, Singapore, South Korea, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026