relapsed/refractory Metastatic urothelial carcinoma MedDRA version: 18.0 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: VECTIBIX - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 10 ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PANITUMUMAB
CAS Num
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. • Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium. Presence of divergent histologies (i.e. squamous-cell tumor, adenocarcinoma, small cell carcinoma, micropapillary variant) may be acceptable provided that there is prevalence (> 50%) of urothelial component. • Locally advanced or metastatic disease. • Age =18 and =75. • Measurable disease criteria, defined as =1 unidimensionally measurable lesion =2 cm by conventional techniques or =1 cm by spiral CT scan. • Failure (i.e. disease relapse/progression by RECIST v1.1 criteria) of one or two platinum-based (either cisplatin or carboplatin) conventional chemotherapy regimen for metastatic disease (second and third-line setting will be the objective of this study). • Neoadjuvant/adjuvant therapy will be counted as one prior chemotherapy line if relapse has occurred within 6 months of the last cycle of chemotherapy. • Female subject is either: o post-menopausal for at least one year before the screening visit, or o surgically sterilized, or o willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 2 months following the last dose of panitumumab. • Male subject, even if surgically sterilized (ie, status postvasectomy), agrees to use an acceptable method for contraception during the entire study treatment period through 2 months after the last dose of panitumumab. • Absolute neutrophil count (ANC) >1,500/mm³, platelets >100,000/mm³, Hgb >9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days, however, erythrocyte growth factor is allowed as per published ASCO guidelines. • Total bilirubin =1.5 x upper limit of nomal (ULN), SGOT (AST) and SGPT (ALT)=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%. • Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen. • Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed. • Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection. • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. • Presence of interstitial pneumonitis, pulmonary fibrosis, evidence of interstitial pneumonitis, or pulmonary fibrosis. • Female subject who is either pregnant or breast-feeding or planning to become pregnant during treatment and within 2 months of the last dose of panitumumab. Confirmation that the subject is not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. • Patient has received other investigational drugs with 14 days before enrollment • Serious medical or psychiatric illness likely to interfere with participation in this clinical study. • Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study. • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. • Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion. For guidance in defining active infection for hepatitis B, please refer to the WHO guidelines. (World Health Organization, Global Alert and Response (GAR), Hepatitis B. who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.html) • Prior administration of an anti EGFR-targeted agent, including but not limited to panitumumab. • Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment. • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression free survival;Secondary Objective: overall survival, toxicity, safety;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): overall survival. safety, toxicity;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
Italy
Contacts
Public ContactTrial center
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed