A DOUBLE-BLIND, PLACEBO-CONTROLLED,RANDOMIZED, MULTICENTER PHASE III STUDYEVALUATING THE EFFICACY AND SAFETY OFPERTUZUMAB IN COMBINATION WITHTRASTUZUMAB AND CHEMOTHERAPY IN PATIENTSWITH HER2-POSITIVE METASTATICGASTROESOPHAGEAL JUNCTION AND GASTRICCANCER.

Not Applicable

• Conditions: -D001 Oesophagus; Oesophagus; D001

• Registration Number: PER-012-13
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-12
• Study Completion: 2019-06-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Gastric adenocarcinoma or histologically confirmed metastatic GEJ (by performing the enrollment center)
2. HER2-positive tumors defined as IHC 3 + or IHC 2 +, the latter in combination with ISH +, as assessed by a central laboratory designated by the sponsor in a primary or metastatic tumor
3. Measurable or evaluable disease not measurable, as assessed by the investigator, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, see Appendix 3
4. Performance status (PS) 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
5. Life expectancy ≥ 3 months
6. Age ≥ 18 years
7. Ability to meet the requirements of the protocol, as assessed by the investigator
8. Signing of Informed Consent.

Exclusion Criteria

1. Prior systemic cytotoxic chemotherapy for advanced disease (metastatic).
2. History of exposure to cumulative doses of anthracyclines following:
a) Epirubicin> 720 mg/m2, b) or doxorubicin liposomal doxorubicin> 360 mg/m2, c) Mitoxantrone> 120 mg/m2 and idarubicin> 90 mg/m2, d) Other (for example, liposomal doxorubicin or other anthracycline greater the equivalent of 360 mg/m2 of doxorubicin) e) If you have used more of an anthracycline, then the cumulative dose should not exceed the equivalent of 360 mg/m2 of doxorubicin.
3. Evidence of documented disease progression in the span of six months after completion of neoadjuvant or adjuvant cytotoxic chemotherapy earlier, or both, or radiotherapy for adenocarcinoma of the gastric or GEJ.
4. Pretreatment with any HER2-directed therapy, at any time and for any duration.
5. Prior exposure to any investigational treatment within the span of 30 days prior to the first dose of study treatment.
6. Radiation in the span of 30 days prior to the first dose of study treatment (within 2 weeks if it is administered as a palliative for bone metastases peripheral, if the patient has recovered from all toxicities).
7. History or evidence of brain metastases.
8. Active GI bleeding clinically significant (≥ Grade 2 according to the Common Terminology Criteria for Adverse Events [CTCAE] v4.03 of the National Cancer Institute [NCI]).
9. Residual toxicity caused by previous therapy (eg hematologic toxicity, neurological or cardiovascular be ≥ Grade 2). Alopecia is permitted.
10. Another malignancy (besides GC) is presented in the span of 5 years prior to enrollment, except for carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin that has been previously treated with curative intent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified