Patients with progressive advanced well-differentiated neuroendocrine carcinomas of non-pancreatic origin (carcinoids) MedDRA version: 14.1 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Axitinib
Product Code: AG-013736
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Axitinib
CAS Number: 319460-85-0
Current Sponsor code: AG-013736
Other descriptive name: NMe
Sponsors
Grupo Español de Tumores Neuroendocrinos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed well differentiated neuroendocrine carcinoma of non-pancreatic origin, either functional or non-functional tumors. 2. Metastatic or locally advanced disease not amenable to treatment with curative intent 3. Progressive disease documented in the prior 12 months (RECIST criteria 1.0) 4. Patients must have at least one measurable lesion as defined by RECIST criteria 1.0. Patients must not have undergone prior local-regional ablative procedures (embolization, cryoablation, radiofrequency ablation or other) within 6 months of study entry unless there are other sites of measurable disease or a clear radiological progression after performance of these procedures (in these cases, prior local-regional ablative procedures not permitted within 1 month of study entry). 5. Ki-67=65 years) y
Exclusion criteria
Exclusion criteria: 1. The following endocrine tumor types may not be included: paraganglioma, adrenal, thyroid, parathyroid or pituitary endocrine tumors. 2. Major surgery in 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 13. History of a malignancy (other than renal cell cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 5 years. 14. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 15. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival (calculated from the date of random assignment until the date of first progressive disease or tumor-related death);Secondary Objective: ?Objective response rate (measured by RECIST 1.1 criteria) and duration of response ?Biochemical response (5-OH-Indolacetic acid and chromogranin A) ?Prognostic and predictive value of F-DOPA-PET-TC ?Overall survival ?Safety and tolerability (National Cancer Institute Common Toxicity Criteria (NCICTC), version 4.0) ?Biomarker assessment (tumoral circulating cells, endothelial circulating cells, hypertension, other serum or tumoral biomarkers of angiogenesis).;Primary end point(s): Progression-free survival (calculated from the date of random assignment until the date of first progressive disease or tumor-related death);Timepoint(s) of evaluation of this end point: Date of first observed progression dissease or the date of death due to any cause (if occurring before progression) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Objective response rate (measured by RECIST 1.1 criteria) and duration of response ? Biochemical response (5-OH-Indolacetic acid and chromogranin A) ? Prognostic and predictive value of F-DOPA-PET-TC ? Overall survival ? Safety and tolerability (National Cancer Institute Common Toxicity Criteria (NCICTC), version 4.0) ? Biomarker assessment (tumoral circulating cells, endothelial circulating cells, hypertension, other serum or tumoral biomarkers of angiogenesis).;Timepoint(s) of evaluation of this end point: Date of irst observed progression dissease or the date of death due to any cause (if occurring before progression) | — |
Countries
Germany, Italy, Spain
Contacts
Public ContactYolanda Martín
TFS
Outcome results
None listed