A study of RO5304020 versus taxane in patients with advanced gastric cancer

Phase 3

• Conditions: Patients who have HER2 -positive advanced gastric cancer

• Registration Number: JPRN-jRCT2080221881
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 412

Inclusion Criteria

ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks from the first dose of study treatment
- Meaasureble and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors(RECIST v1.1)
- Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization
- Patients must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease.
- HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing
- Patients must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.
- First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.
- Adjuvant or neoadjuvant chemotherapy for AGC is allowed.

Exclusion Criteria

- An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
- Prior treatment with RO5304020, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen.
- Treatment with any investigational anticancer drug within 21 days of the first study treatment administration.
- More than one prior line of therapy for advanced gastric cancer.
- History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
- Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization
- Peripheral neuropathy Grade >/=2
- Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)
- Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
- Clinically significant bleeding within 30 days before enrollment
- For female patients, current pregnancy or lactation
- Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- Infection with HIV or hepatitis B virus, hepatitis C virus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)

Secondary Outcome Measures

Name	Time	Method
- Objective response rate (ORR) <br>- Progression-free survival (PFS) <br>- Duration of response (DOR) <br>- Safety: incidence of adverse events <br>- Response distribution of treatment-related symptoms as measured by patient-reported outcome data <br>- Time to gastric cancer symptom progression Quality of life as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) <br>RECIST version 1.1, NCI CTCAE(v. 4.03)