Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors
|ClinicalTrials.gov Identifier: NCT00958724|
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Tumors||Drug: Neratinib Drug: Vinorelbine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Of Neratinib (HKI-272) In Combination With Vinorelbine In Japanese Subjects With Advanced Or Metastatic Solid Tumors|
|Actual Study Start Date :||July 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Neratinib and Vinorelbine
Neratinib: 240 mg administered daily by mouth continuously, Vinorelbine: 25 mg/m^2 administered IV on Day 1 and 8 of 21 day cycle
- DLT of Neratinib in Combination With Vinorelbine [ Time Frame: From first dose date to 21st day ]Incidence of DLT of neratinib in combination with vinorelbine in Japanese patients
- Best Overall Response [ Time Frame: From first dose date to progression or last tumor assessment ]Best Overall Response in Evaluable Population.
- Duration of Objective Response [ Time Frame: From first response date to PD/death ]The duration of objective response was measured from the time at which measurement criteria were met for CR or PR (whichever status was recorded first) until the first date on which recurrence or PD was objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.
- Objective Response Rate [ Time Frame: From first dose date to progression or last tumor assessment ]The Objective Response Rate (ORR) was defined as the proportion of subjects who achieved complete response (CR) or partial response (PR).
- PFS, in Weeks [ Time Frame: From first dose to last evaluation ]The interval from the date of the first dose of test article until the first date on which recurrence or progression, or death due to any cause, was documented, censored at the last evaluation.
- AUC Tau of Neratinib in Combination With Vinorelbine [ Time Frame: Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8. ]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.
- t 1/2 of Neratinib in Combination With Vinorelbine [ Time Frame: Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958724
|Shizuoka Cancer Center|
|Shizuoka, Japan, 411-8777|
|The Cancer Institute Hospital of Japanese Foundation for Cancer Research|
|Tokyo, Japan, 135-8550|