Phase I/II Trial of BIBW 2992 (Afatinib) in Treating Patients With Recurrent Glioblastoma Multiforme

简要总结

主要结局

次要结局

• Objective Tumor Response in Phase II(From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days)
• Progression-free Survival (PFS)- Phase II Part(from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.)
• Objective Tumor Response in Phase I(From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.)
• Cmax for Temozolomide(Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1)
• Number of Participants With PTEN Marker Assessed by IHC Test.(Baseline (during screening))
• AUCτ,ss for Afatinib(Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1)
• Cmax,ss for Afatinib(Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1)
• Tmax,ss for Afatinib(Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1)
• AUC (0-8) for Temozolomide(Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1)
• Number of Participants With Chromosomes (CEP7) Assessed by FISH(Baseline (during screening))
• Number of Participants With Chromosomes (CEP10) Assessed by FISH(Baseline (during screening))
• Number of Participants With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, All Serious Adverse Events (AE) and Other Significant AEs - Phase I(From first administration of treatment until 28 days after last drug administration, up to 491 days.)
• Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase I(From first administration of treatment until 28 days after last drug administration, up to 491 days.)
• Number of Participants With Adverse Events, Graded According CTCAE - Phase I(From first administration of treatment until 28 days after last drug administration, up to 491 days.)
• Causes of Death - Phase I(From first administration of treatment until 28 days after last drug administration, up to 491 days.)
• Number of Participants With Investigator Defined Drug-Related AEs, AE Leading to Dose Reduction, AEs Leading to Discontinuation of Trial Drug and All SAE- Phase II(From first administration of treatment until 28 days after last drug administration, up to 518 days.)
• Tmax for Temozolomide(Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1)
• Phase II - Trough Plasma Concentration of Afatinib(Before (-0.05 h) the drug administration of afatinib on Day 15 of Cycle 2 & 3)
• Number of Participants With EGFRvIII Assessed by IHC Test.(Baseline (during screening))
• t1/2 for Temozolomide(Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1)
• Number of Participants With PTEN Assessed by FISH(Baseline (during screening))
• Number of Participants With MGMT Marker Assessed by IHC Test.(Baseline (during screening))
• Number of Participants With EGFR Marker Assessed by IHC Test.(Baseline (during screening))
• Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase II(From first administration of treatment until 28 days after last drug administration, up to 518 days.)
• Number of Participants With Adverse Events, Graded According CTCAE - Phase II(From first administration of treatment until 28 days after last drug administration, up to 518 days.)
• Causes of Death - Phase II(From first administration of treatment until 28 days after last drug administration, up to 518 days.)
• Number of Participants With Clinically Relevant Abnormalities for Decreased Cardiac Left Ventricular Function - Phase II(From first administration of treatment until 28 days after last drug administration, up to 518 days.)
• Number of Participants With PAKT Marker Assessed by IHC Test.(Baseline (during screening))
• Number of Participants With EGFR Assessed by FISH(Baseline (during screening))