A randomized, multicenter, open-label study evaluating two different doses of pertuzumab in patients with HER2-positive advanced gastric cancer
- Conditions
- HER2-positive adenocarcinoma of the stomach or gastroesophageal junctionMedDRA version: 14.0Level: LLTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002331-25-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Disease-Specific Inclusion Criteria
? Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy. Patients with advanced disease who present with a recurrence post operatively (when intent of surgery was cure) are also eligible for entry.
? Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1, assessed using imaging techniques (CT or MRI), or non-measurable disease that can be followed
? HER2 positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH +, as assessed by central laboratory on primary or metastatic tumor ISH positivity is defined as a ratio of >= 2.0 for the number of HER2 gene copies to the number of signals for CEP17.
Availability of formalin-fixed paraffin-embedded (FFPE) tissue with at least 5 mm of invasive tumor for central confirmation of HER2 eligibility is mandatory.
? Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
? Baseline LVEF >= 55% (measured by ECHO or MUGA)
? Life expectancy of at least 3 months.
General Inclusion Criteria
? Male or female
? Age >= 18 years
? Signed informed consent
? For women of childbearing potential and male participants with partners of childbearing potential: agreement to use a highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner (see Section 7.2.6 for details). Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Cancer-Related Exclusion Criteria
? Previous chemotherapy for advanced or metastatic disease, except that prior adjuvant or neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant or neoadjuvant therapy and enrollment in the study. Adjuvant or neoadjuvant treatment with platinum-based therapy is not allowed.
? Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g., patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe)
? Active (significant or uncontrolled) gastrointestinal bleeding
? Residual relevant toxicity resulting from previous therapy (e.g., neurological toxicity of >= Grade >= 2 [NCI CTCAE]), with the exception of alopecia
? Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
Exclusion Criteria Related to Hematological, Biochemical, and Organ Function
? Any of the following abnormal laboratory tests immediately prior to randomization:
Serum total bilirubin > 1.5 times the upper limit of normal (ULN) or, for patients with known Gilberts syndrome, serum total bilirubin > 2 × ULN
For patients with no liver and no bone metastases:
AST or ALT > 2.5 × ULN, and alkaline phosphatase (ALP) > 2.5 × ULN
In patients with liver metastases and no bone metastases:
AST or ALT > 5 × ULN, and ALP > 2.5 × ULN
In patients with liver metastases and bone metastases:
AST or ALT > 5 × ULN, and ALP > 10 × ULN;
In patients with bone metastases and no liver metastases:
AST or ALT > 2.5 × ULN, and ALP > 10 × ULN
Albumin < 25 g/L
Creatinine clearance < 60 mL/min
Total WBC count < 2500/?L (< 2.5 × 109/L)
Absolute neutrophil count (ANC) < 1500/?L (<1.5 × 109/L)
Platelets < 100,000/?L (<100 × 109/L).
Other Study Drug?Related Exclusion Criteria
? Serious cardiac illness or medical conditions including but not confined to:
History of documented heart failure or systolic dysfunction (LVEF < 50%)
High-risk uncontrolled arrhythmias, such as atrial tachycardia with a heart rate >= 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV block (second-degree AV block Type 2 [Mobitz II] or third-degree AV block)
Angina pectoris requiring anti-anginal medication
Clinically significant valvular heart disease
Evidence of transmural infarction on ECG
Poorly controlled hypertension (e.g., systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg)
? Dyspnea at rest due to complications of advanced malignancy or other disease, or requirement for supportive oxygen therapy
? Treatment with chronic or high-dose corticosteroid therapy.
Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed.
? Clinically significant hearing abnormality
? Known dihydropyrimidine dehydrogenase deficiency.
General Exclusion Criteria
? History or clinical evidence of brain metastases
? Serious uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
? Pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization, irrespective of the method of contraception used.
? Radiotherapy within 4 weeks prior to start of study treatment, or within 2 weeks prior to start of study treatment if palliative radiotherapy is given to bone metastatic site peripherally and patient recovers from any acute toxicity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method