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: 14.1Level: PTClassification code 10061968Term: Gastric neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002331-25-IT
- Lead Sponsor
- ROCHE
- 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 nonhormonal 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: 0
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/µL(<2.5 × 109/L); Absolute neutrophil count (ANC) <1500/µL (<1.5 × 109/L); Platelets < 100,000/µL (<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
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