The purposes of this study are to evaluate the safety and tolerability of neratinib in combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors in Japanese patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Shizuoka Cancer Center
Shizuoka, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan
Dose Limiting Toxicity (DLT)
Number of participants experiencing DLT of neratinib in combination with vinorelbine in Japanese patients.
Time frame: From first dose date to 21st day
Best Overall Response
Best Overall Response in Evaluable Population per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From first dose date to progression or last tumor assessment, up to 40 weeks.
Duration of Objective Response
The duration of objective response was measured from the time at which measurement criteria were met for Complete Response (CR) or Partial Response (PR) (whichever status was recorded first) until the first date on which recurrence or Progressive Disease (PD) was objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.
Time frame: From first response date to PD/death, up to 40 weeks.
Objective Response Rate (ORR)
Proportion of subjects who achieved complete response or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From first dose date to progression or last tumor assessment, up to 40 weeks.
Progression Free Survival
Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Disease Progression (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.
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Time frame: From first dose to last evaluation, up to 40 weeks.
Area Under the Curve (AUC) Tau
AUC of Neratinib at day 8 following administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m\^2 to Japanese Subjects with Cancer.
Time frame: Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.
Terminal-phase Elimination Half-life
Terminal-phase elimination half-life of Neratinib at day 8 following Administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m\^2 to Japanese Subjects with Cancer.
Time frame: Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.