Patients with advanced gastric cancer or gastroeosophageal junction (Types II & III) adenocarcinoma will be investigated. Patients will be given TP300 as a single agent as first line therapy administered every 3 weeks. MedDRA version: 12.0 Level: PT Classification code 10017758 Term: Gastric cancer MedDRA version: 12.0 Level: PT Classification code 10001141 Term: Adenocarcinoma
Conditions
Interventions
Product Name: TP300
Product Code: CH4556300-003
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: TP103 EU
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
CHUGAI PHARMA EUROPE LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient can be included in the study only if they meet all of the following criteria: 1. Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma (Siewart type II or III). 2. Male or female aged = 18 years. 3. ECOG performance status of 0 or 1. 4. Life expectancy of ³ 3 months. 5. Disease measurability, which can be assessed using the RECIST 1.1 criteria. 6. Adequate bone marrow function as defined by: absolute neutrophil count (ANC) of ³ 1.0 109/L, platelet count of ³ 100 109/L, and haemoglobin of ³ 9 g/dL. 7. Adequate liver function, as determined by: • Serum total bilirubin £ 1.5 (upper limit of normal [ULN]), aspartate amino transferase (AST) and alanine amino transferase (ALT) £ 2.5 ULN (£ 5 ULN if liver metastases); alkaline phosphatase (ALP) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons: 1. Patients with known (past or present) central nervous system (CNS) metastases. 2. Prior chemotherapy, radiotherapy (other than local palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receiving study drug. 3. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before study treatment. 4. Prior toxicities from chemotherapy or radiotherapy that have not regressed to Grade £1 severity (NCI CTCAE version 3.0). 5. Prior corticosteroids as anti-cancer therapy within a minimum of 21 days of first receiving study drug. 6. No prior chemotherapy for (advanced, metastatic, or recurrent) gastric or gastro-oesophageal adenocarcinoma is allowed. Patients are allowed to have received prior neoadjuvant or adjuvant chemotherapy/chemo-radiation but at least 12 months should have elapsed since completion of neoadjuvant or adjuvant therapy. 7. Treatment with any investigational agent within 28 days of first receiving study drug. 8. Patients with active or uncontrolled infection. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient. Examples of such medical conditions include significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina pectoris) or severe obstructive pulmonary disease. 9. Major surgery within 28 days of first receiving study drug. 10. Pregnant or lactating women. 11. Altered mental status or psychiatric disorder that in the opinion of the investigator would preclude a valid patient informed consent. 12. Previous history of malignancy in the last 5 years except carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the objective response (OR), defined as complete or partial response (CR/PR), assessed in accordance with the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.;Secondary Objective: 1. To assess progression-free survival (PFS), which is defined as being dated from the time of first dose until the date of disease progression or death whichever occurs first. 2. To assess the time to progression (TTP), defined as the time from first dose to first progression of disease. 3. To assess the safety and tolerability of TP300. 4. To further assess pharmacokinetic (PK) characteristics of TP300 active form and active metabolite. ;Primary end point(s): Primary endpoint: The primary endpoint will be objective response, defined as CR or PR, assessed in gastric cancer in accordance with the RECIST 1.1 criteria in solid tumours. Patients will have a computerised tomography (CT) scan after 2 cycles of treatment. The same radiographic procedure used at baseline must be used through the study. | — |
Countries
United Kingdom
Outcome results
None listed