A randomised phase 2 study of paclitaxel with or without GSK1120212 or pazopanib in advanced wt BRAF melanoma - Paclitaxel +/- GSK1120212 or pazopanib in Melanoma

niversity of Oxford0 sites138 target enrollmentJuly 28, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 28, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Aged \= 18 years
•2\. Able to provide evidence from an accredited laboratory of wt BRAF status for their melanoma, or ascertainment of wt BRAF status from a sample of melanoma provided for mutational analysis in Oxford (phase 2 part only).
•3\. Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma
•4\. Measurable disease as defined by RECIST 1\.1 (phase 2 part only).
•5\. ECOG performance score of 0 or 1\.
•6\. Life expectancy of at least 12 weeks.
•7\. Adequate cardiac function (NYHA 0\-1\), and LVEF within normal limits on echocardiogram.
•8\. The patient is willing to give consent to the main study and able to comply with the protocol for the duration of the study, including scheduled follow\-up visits and examinations.
•9\. Adequate haematological, hepatic and renal function.
•Are the trial subjects under 18? no

•1\. Any systemic anti\-cancer therapy (including participation in other clinical trials) within 28 days prior to Day 1 (42 days prior for ipilimumab).
•2\. Any radiotherapy within 14 days prior to Day 1\.
•3\. Prior taxane or BRAF or MEK inhibitors for metastatic melanoma.
•4\. Any unresolved toxicity from prior anti\-cancer therapy that is greater than CTCAE grade 2\.
•5\. Pregnancy or breastfeeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post\-menopausal status (defined as absence of menstruation for \> 12 months, bilateral oophrectomy or hysterectomy).
•6\. Grade \=2 peripheral neuropathy at study entry.
•7\. Patients of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (both male and female patients)
•8\. Known severe hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor EL and ethanol
•9\. Ocular or mucosal malignant melanoma
•10\. Another active malignancy within the past three years.