Advanced metastatic melanoma
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Product Code: N/A
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: docetaxel
CAS Number: 114977-28-5
Concentrati
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: BRAF Mutation Screening • In the opinion of the investigator the patient is likely to fulfil the eligibility criteria of the main study Main Study • = 16 years of age, written informed consent • Histologically confirmed, wild type BRAF, metastatic melanoma. • Unresectable Stage III or Stage IV metastatic melanoma. • Measurable disease as defined by modified RECIST criteria. • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. • Adequate haematological, hepatic and renal function. • Adequate cardiac function (NYHA 0-1). • No evidence of brain metastases or treated brain metastasis with no evidence of relapse on cerebral MRI, or stable off treatment for 3 months. • Life expectancy > 12 weeks. • LDH = 2xULN. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: BRAF Mutation Screening • In the opinion of the investigator the patient is not likely to fulfil the eligibility criteria of the main study Main Study • Radiotherapy or systemic melanoma therapy within 28 days prior to starting treatment. • Prior DNA damaging agents or BRAF or MEK inhibitors for metastatic melanoma • Pregnancy or breastfeeding woman • Grade = 2 peripheral neuropathy at study entry • Known severe hypersensitivity to drugs formulated in polysorbate 80 • Ocular or mucosal malignant melanoma • Another active malignancy within the past five years • Clinically significant and uncontrolled major medical condition(s). • Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption of AZD6244. • Taking medication known to interact significantly with CYP3A4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of AZD6244 in combination with docetaxel, compared with docetaxel alone, in first line treatment of patients with wild type BRAF advanced malignant melanoma.;Secondary Objective: To assess the safety and tolerability of AZD6244 in combination with docetaxel compared with docetaxel alone. To assess the impact of tumour characteristics on response to docetaxel therapy with or without AZD6244;Primary end point(s): Progression free survival | — |
Countries
United Kingdom
Outcome results
None listed