Phase 2
Completed N=30
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Source: ClinicalTrials.gov NCT01461057 ↗Enrolled (actual)
30
Serious AEs
70.0%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) — 91.6; 98.3 percentage of participants
Summary
This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) |
91.6; 98.3 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
15; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, greater than or equal to (>=) 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
Data sourced from ClinicalTrials.gov (NCT01461057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.