A Phase II, open label, single arm study to evaluate Ticilimumab in Advanced Gastric/Oesophageal Adenocarcinoma

• Conditions: Advanced Gastric/Oesophageal Adenocarcinoma

• Registration Number: EUCTR2005-005660-86-GB
• Lead Sponsor: Christie Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To be eligible for the study, patients must satisfy all of the following criteria:
1. Histologically confirmed gastric or oesophageal adenocarcinoma that is locally advanced or metastatic.
2. Prior treatment with appropriate chemotherapy.
3. Patients with persistent or progressive disease post chemotherapy or patients who could not tolerate previous treatment due to unacceptable toxicity.
4. A minimum of one measurable lesion on CT scan according to RECIST. See Appendix 2 for details.
5. ECOG performance status (PS) 0 or 1.
6. Life expectancy > 3 months.
7. Age = 18 years.
8. Female patients must be surgically sterile or be postmenopausal for at least two years, or must agree to use effective contraception during the period of treatment and 6 months after. Women of child bearing potential must have a negative pregnancy test prior to entry and within 72 hours prior to receiving each cycle of ticilimumab.
9. Adequate bone marrow, hepatic and renal function determined within 14 days prior to enrollment, defined as:
• Absolute neutrophil count = 1.5 x 109 cells/L
• Platelets = 100 x 109 cells/L
• Haemoglobin = 9.0g/dL
• Aspartate and Alanine aminotransferases (AST, ALT) = 2.5 x ULN 5 x ULN if documented liver metastases are present)
• Total bilirubin = 2 x ULN (except for patients with documented Gilbert’s syndrome)
• Serum creatinine =170µmol/L
10. Patients must have recovered from all prior treatment-related toxicities, to baseline status, or to NCI CTCAE v3 Grade 0 or 1, except for toxicities not considered a safety risk such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy. Post-surgical pain shall not be considered a basis for exclusion.
11. Must be willing and able to provide written informed consent.
12. Must be willing and able to comply with Study procedures
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Received treatment for cancer within 4 weeks prior to enrollment (dosing), 12 weeks for immunotherapy.
2. Received any prior anti-CTLA4-inhibiting agent.
3. History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders etc.). Vitiligo will not be a basis for exclusion.
4. History of, or clinically apparent hepatitis B or hepatitis C.
5. History of inflammatory bowel disease, celiac disease or other chronic gastrointestinal conditions associated with diarrhoea or bleeding, or current acute colitis of any origin.
6. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (Note: inhaled or topical steroids in standard doses are allowed).
7. Known brain metastases.
8. Prior or concurrent malignancy within the last 5 years other than basal cell carcinoma or in situ carcinoma of the uterine cervix.
9. Evidence of uncontrolled cardiac or respiratory disease or other serious medical or psychiatric disorders that would be a contra-indication to study procedures.
10. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the study.
11. Pregnancy or breast-feeding.

Study & Design

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