A study comparing the combination of cisplatin and capecitabine plus E7050 to cisplatin and capecitabine alone for the treatment of cancerous tumors and stomach cancer

• Conditions: Advanced or metastatic solid tumors and previously untreated gastric cancer; MedDRA version: 14.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000774-58-GB
• Lead Sponsor: Eisai Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Patients may be entered in the study only if they meet all of the following criteria:

1. Male or female patient =18 years of age;

2. Histologically confirmed, unresectable, locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (Phase II). For the Phase Ib portion, any unresectable, locally advanced or metastatic solid tumor;

3. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v. 1.1) criteria;

4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1;

5. Adequate hematologic, renal, liver, and coagulation system function as defined by laboratory values performed within 21 days prior to initiation of dosing:
Absolute neutrophil count (ANC) =1.5 x 109/L;
Platelet count =100 x 109/L;
Hemoglobin =9 g/dL;
Serum creatinine =1.5 X ULN and/or creatinine clearance =60 mL/min
per the Cockcroft and Gault formula;
Total serum bilirubin =1.5 X ULN;
Serum aspartate transaminase (AST/SGOT) or serum alanine
transaminase (ALT/SGPT) =2.5 X ULN, and =5 X ULN if liver
metastases are present. If there are bone metastases, liver-specific
alkaline phosphatase may be separated from the total and used to
assess liver function instead of total alkaline phosphatase;
PT/International normalized ratio (INR) =1.5 X ULN;
PTT =1.1 X ULN;

6. For patients with hypertension, it must be well controlled. If a patient presents with poorly controlled hypertension, defined as a mean systolic blood pressure =140 mm Hg or mean diastolic blood pressure =90 mm Hg, antihypertensive medication(s) should be initiated or adjusted with a goal to control the blood pressure <140/90 mm Hg. Blood pressure must be reassessed on 2 occasions, consecutively, that are separated by a minimum of 24 hours;

7. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment;

8. Females of childbearing potential must have a negative serum pregnancy test at screening;

9. Females may not be breastfeeding;

10. Ability to understand and willingness to sign a written informed consent.
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Patients will not be entered in the study for any of the following reasons:

1. Gastric cancer patients who have had a complete gastrectomy;

2. Patients with known HER2 over-expressing advanced or metastatic gastric cancer;

3. Prior treatment with E7050, its chemical derivatives or prior anti-c-Met therapy;

4. Prior anti-angiogenic therapy (permitted in Phase Ib);

5. For Phase Ib prior systemic therapy is allowed as long as PS and end organ function meet entry criteria;

6. For Phase II no prior palliative chemotherapy is permitted. Adjuvant or neoadjuvant chemotherapy is permitted if >12 months have elapsed between the end of adjuvant or neoadjuvant therapy and first recurrence;

7. Known central nervous system lesions, except for asymptomatic non-progressing, treated brain metastases. Treated brain metastases are defined as having no evidence of progression or hemorrhage, as ascertained by clinical examination and brain imaging (MRI or CT) during the Screening period. Treatment for brain metastases must have been completed at least 4 weeks prior to Day 1 and may include whole brain radiotherapy, radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Dexamethasone must be discontinued at least 3 weeks prior to Day 1;

8. History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, or b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for =3 years;

9. Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade =1, except for peripheral neuropathy (Grade 1 and Grade 2 are permitted) and alopecia;

10. Are currently receiving any other anti-cancer treatment;

11. Palliative radiotherapy is not permitted throughout the study period. Prior palliative radiotherapy within 30 days prior to commencing study treatment;

12. CTCAE Grade =3 peripheral neuropathy (Grade 1 and Grade 2 are permitted);

13. Patients with known dihydropyrimidine dehydrogenase deficiency;

14. Patients with clinically significant hearing loss that may be further diminished by treatment with cisplatin plus capecitabine (significance of hearing loss to be determined by the Investigator);

15. Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 21 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if =7 days have passed;

16. History of bleeding diathesis or coagulopathy;

17. History of bleeding varices;

18. Active hemoptysis (defined as bright red blood of ½ teaspoon or more) within the 30 days prior to study entry;

19. Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg, variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose;

20. History of untreated deep venous thrombosis within the past 6 months (eg, calf vein thrombosis), or history of portal vein thrombosis;

21. Refractory nausea and vomiting, malabsorption, significant bowel resect

Study & Design

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