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An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer


Inclusion Criteria:



- Adult patients, >/= 18 of age

- adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally
advanced or metastatic disease, not amenable to curative therapy

- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors
(RECIST), v1.1

- HER2-positive tumor

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of at least 3 months

Exclusion Criteria:

- Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or
neoadjuvant therapy at least 6 months before enrollment in the study)

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome

- Active (significant or uncontrolled) gastrointestinal bleeding

- Abnormal laboratory values

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Minimum (trough) pertuzumab concentration (Cmin)

Outcome Time Frame:

Day 43

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

BP27836

NCT ID:

NCT01461057

Start Date:

December 2011

Completion Date:

May 2016

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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