Patient population includes patients with Advance gastric cancer, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients must have measurable disease and must not have received prior systemic anticancer therapy for advance or metastatic gastric cancer. Indicación: Cáncer Gastrico Avanzado MedDRA version: 9 Level: PT Classification code 10061967 Term: Gastric cancer stage IV
Conditions
Interventions
Product Name: Telatinib
Product Code: ACTB 1001-b
Pharmaceutical Form: Tablet
INN or Proposed INN: Telatinib
CAS Number: 75747-14-7
Current Sponsor code: ACTB 1001-b
Other descriptive name: Telatinib
formerly known as BAY 60-8524
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Product Name: Capecitabine
Pharmaceutical Form: Film-coated tablet
INN or Propos
Sponsors
ACT BIOTECH, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Histologically or cytologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy 3. At least 1 measurable lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST), and be documented by radiological evaluation within 28 days prior to study entry (4. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at study entry 5. Prior radiation therapy completed at least 28 days prior to study entry (if applicable) 6. Adequate bone marrow, liver, and renal function at study entry as assessed by: ? Hemoglobin > 9.0 g/dL (transfusion and growth factor independent) ? Platelet count > 100,000/µL (transfusion independent) ? Absolute neutrophil count (ANC) > 1500/µL (growth factor independent) ? Total bilirubin 60 mL/min. The Cockroft and Gault formula (Section 12.7) is recommended for calculation of creatinine clearance. Subjects with a calculated creatinine clearance below 60 mL/min may be eligible if a measured creatinine clearance (based on 24 hour urine collection or other reliable method) is > 60 mL/min 7. Negative serum pregnancy test performed within 7 days prior to study entry for women of childbearing potential 8. Women and men of childbearing potential must agree to use adequate contraception (e.g., condom, intrauterine device (IUD), oral contraceptive, or double-barrier method), prior to study entry, for the duration of study participation and 28 days after the last study drug dosing 9. Able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures. 10. Able to comply with study procedures and follow-up examinations 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
Exclusion criteria: 1. Previous chemotherapy for locally advanced or metastatic gastric cancer. Subjects may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to study entry. 2. Previous anti-angiogenic therapy (i.e. anti-VEGF or VEGFR tyrosine kinase inhibitor such as bevacizumab, sorafenib,sunitinib, AZD2171) 3. Previous total platinum dose >300 mg/m2 [Total prior platinum dose of class II New York Heart Association (NYHA) (Section 12.5), or ? Unstable angina (anginal symptoms at rest), or newonset angina (began within the last 12 months), or myocardial infarction within the 12 months prior to enrolment, or ? Cardiac ventricular arrhythmias requiring antiarrhythmic therapy ? Atrial fibrillation or atrioventricular heart block 7. Uncontrolled hypertension at study entry (systolic blood pressure >150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management 8. Any (including pulmonary) hemorrhage/bleeding event > grade 3 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 within 28 days prior to study entry 9. Major surgery, open biopsy, or significant traumatic injury within 28 days prior to study entry 10. Current serious, non-healing wound, ulcer, or bone fracture at study entry 11. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry 12. Active clinically serious infection > grade 3 by NCI-CTCAE v.3.0 at study entry 13. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B (HBV) or C (HCV). The safety of telatinib in this subject population has not been studied. 14. Previous or concurrent cancer that is distinct in primary site or histology from gastric cancer. Subjects with cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years prior to study entry are eligible. 15. Anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy or tumor embolization) or investigational agent within 28 days prior to study entry 16. Known or suspected allergy to any component of telatinib, cisplatin or capecitabine 17. Known dihydropyrimidine dehydrogenase (DPD) deficiency 18. Unable to take oral medications (because of certain circumstances such as malabsorption, difficulty swallowing, or other conditions) that could affect oral intake of capecitabine and telatinib 19. Prior or current history of substance abuse, or medical, psychological, or social condition that in the opinion of the investigator may interfere with the subject?s participation in the study or evaluation of the study result 20. Women who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival (PFS);Secondary Objective: Overall survival (OS) Overall response rate (ORR) Safety and tolerability Pharmacokinetics and biomarkers;Primary end point(s): The primary endpoint is PFS. For the primary analysis of PFS, PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression according to RECIST or the date of symptomatic deterioration if it occurs prior to progression according to RECIST, or the date of death due to any cause (if occurring before progression). For subjects without documented progression or death at the time of analysis, the date of PFS will be censored at the last date of tumor assessment. If a subject has no tumor assessments after Screening (Baseline), then the subject will be censored at day 1. | — |
Countries
Spain
Outcome results
None listed