None listed
Conditions
Interventions
Two treatment arms (Arm A or Arm B). Arm A will receive 300 mg daily of ASP8273 and Arm B will receive either 150 mg erlotinib or 250 mg gefitinib daily, as decided by the investigator prior to random
Sponsors
ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.2. Subject is ≥ 18 years of age.3. Subject agrees not to participate in another interventional study while on treatment.4. Female subject must either: Be of nonchildbearing potential: postmenopausal prior to Screening, or documented surgically sterile. if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration And have a negative serum pregnancy test at Screening And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control.5. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.6. Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.7. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control. .FOR MORE DETAILS PLEASE SEE THE PROTOCOL
Exclusion criteria
Exclusion criteria: 1. Subject has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ≥ 6 months before the first dose of study drug.2. Subject has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib,dacomitinib, ASP8273, etc).3. Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.4. Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.5. Subject has symptomatic central nervous system (CNS) metastasis. 6. Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug. PARA MAYOR DETALLE VER LA SECCION DE CRITERIOS EN EL PROTOCOLO CLINICO
Countries
Argentina, Australia, Brazil, Canada, Chile, France, Germany, Hungary, Italy, Japan, Korea North, Korea South, Malasya, Netherlands, Portugal, Romania, Russian Federation, Singapore, Spain, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactBertha Del Pilar Cabrera
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed