Phase II, open-label, multi-centre study of TP300 as a single agent as first line therapy in patients with advanced gastric cancer or gastroeosophageal junction adenocarcinoma. - TP103E

• Conditions: 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: 12.0Level: PTClassification code 10017758Term: Gastric cancer; MedDRA version: 12.0Level: PTClassification code 10001141Term: Adenocarcinoma

• Registration Number: EUCTR2009-012097-12-GB
• Lead Sponsor: CHUGAI PHARMA EUROPE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

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) < 2.5 ULN (< 5 ULN if liver metastases).
•Normal albumin.
•There is no upper limit for ALP if elevation is due to bone metastases.
8.Adequate renal function shown by serum creatinine = 1.5 ULN.
9.Signed informed consent.
10.Ability to comply with protocol requirements (visits and assessment schedules) and willingness to allow blood sampling.
11.Females must be post-menopausal (12 months of amenorrhea), surgically sterile, or must agree to use a physical method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception.
12.Male patients must be surgically sterile or agree to use a barrier method of contraception.
13.Female patients of child bearing potential must have a negative urine pregnancy test within the 7 days before study drug administration.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified