Safety and Tolerability of Trametinib in Combination With Docetaxel in Japanese Subjects With Non-small Cell Lung Cancer
- Conditions
- Lung Cancer, Non-Small Cell
- Interventions
- Registration Number
- NCT01938456
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The primary purpose of this study is to evaluate the safety and tolerability of the combination therapy of trametinib and docetaxel with growth factor support in Japanese subjects with Stage IV or a postoperative recurrence non-small cell lung cancer (NSCLC). This study data will be used for making decision for further Japanese development plan for NSCLC. Six evaluable subjects will be enrolled in a dose level to evaluate the safety and tolerability of the combination treatment. Dose-limiting toxicity will be assessed during the first 21 days of combination therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trametinib + Docetaxel + Filgrastim Trametinib Participants will receive Trametinib once daily for 21 days of each cycle + Intravenous Docetaxel once every three weeks over at least a one-hour infusion + Filgrastim (growth factor) subcutaneous injection once daily for prophylactic use. Trametinib + Docetaxel + Filgrastim Docetaxel Participants will receive Trametinib once daily for 21 days of each cycle + Intravenous Docetaxel once every three weeks over at least a one-hour infusion + Filgrastim (growth factor) subcutaneous injection once daily for prophylactic use. Trametinib + Docetaxel + Filgrastim Filgrastim Participants will receive Trametinib once daily for 21 days of each cycle + Intravenous Docetaxel once every three weeks over at least a one-hour infusion + Filgrastim (growth factor) subcutaneous injection once daily for prophylactic use.
- Primary Outcome Measures
Name Time Method Change from baseline in laboratory parameter values. Baseline and up to 6 months Laboratory parameters include: hematology, clinical chemistry, coagulation tests and urinalysis tests.
Change from baseline in vital sign values Baseline and up to 6 months Vital sing measurement include: temperature, systolic blood pressure, diastolic blood pressure, heart rate, and blood oxygen saturation (SpO2)
Number of participants with Adverse events (AEs). Baseline and up to 6 months AEs will be collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice
- Secondary Outcome Measures
Name Time Method Composite of pharmacokinetic (PK) parameters for PK samples will be collected at pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 24 hours (pre-dose) post-dose/infusion start PK parameters include: area under the concentration time curve over dosing interval (AUC\[0 to tau\]), maximum observed concentration (Cmax), time of occurence of Cmax (tmax), and pre-dose (trough) concentration at the end of the dosing interval
Composite of PK parameters for Docetaxel PK samples will be collected at pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 24 hours (pre-dose) post-dose/infusion start PK parameters include: area under the concentration time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0 to infinite\]), area under the concentration time curve from time zero to last quantifiable concentration within subject across all treatments (AUC\[0 to t\]), Cmax, tmax, systemic clearance of parent drug (CL), and volume of distribution (V)
Tumor response as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 6 months As per RECIST v1.1 the response will be assessed from target lesion as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), not applicable (NA) or not evaluable (NE) and from non-target lesion as CR, Non-CR/Non-PD, NA or NE