Clinical trial NCT01256359 (phase 2, status: unknown status)
Conditions: melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: docetaxel and azd6244, docetaxel and placebo
SMILES: CN1C=NC2=C1C=C(C(O)=NOCCO)C(NC1=C(Cl)C=C(Br)C=C1)=C2F, [H][C@@]12C[C@H](O)[C@@]3(C)C(=O)[C@H](O)C4=C(C)[C@H](C[C@@](O)([C@@H](OC(=O)C5=CC=CC=C5)[C@]3([H])[C@@]1(CO2)OC(C)=O)C4(C)C)OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Aged >/= 16 years

          -  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.

          -  Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma

          -  At least 1 lesion, not previously irradiated, that can be accurately measured on CT or
             MRI as defined by modified RECIST criteria

          -  ECOG performance score of 0 or 1.

          -  Life expectancy of at least 12 weeks.

          -  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.

          -  Haematological and biochemical indices within the ranges shown below. Lab Test Value
             required Haemoglobin (Hb) >10g/dL White Blood Count (WBC) > 3x109/L Platelet count >
             100,000/μL Absolute Neutrophil count > 1.5x109/L; Serum bilirubin ≤ 1.2 x ULN AST
             (SGOT) or ALT ≤ 2.5 x ULN LDH ≤ 2 x ULN Creatinine clearance (Cockcroft-Gault) >50
             ml/min

        Exclusion Criteria:

          -  Any anti-cancer therapy (including radiotherapy and participation in other clinical
             trials) within 28 days prior to Day 1.

          -  Prior DNA damaging agents or cytotoxic chemotherapy for metastatic melanoma.

          -  Any unresolved toxicity from prior anti-cancer therapy that is greater than CTCAE
             grade 2.

          -  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).

          -  Grade ≥2 peripheral neuropathy at study entry.

          -  Patients of reproductive potential who are not willing to use adequate contraceptive
             measures for the duration of the study (both male and female patients)

          -  Known severe hypersensitivity reactions to docetaxel or other drugs formulated in
             polysorbate 80

          -  Ocular or mucosal malignant melanoma

          -  Another active malignancy within the past five years.

          -  Evidence of brain metastases, unless surgically resected/stereotactic radiosurgery
             treated brain metastasis with no evidence of relapse on cerebral MRI, or treated brain
             metastasis and stable off treatment, including steroids, for 3 months.

          -  Clinically significant and uncontrolled major medical condition(s): such as active
             infection, bleeding diathesis.

          -  Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or
             HIV.

          -  Cardiac conditions, including uncontrolled hypertension (BP>160/100 despite
             treatment), heart failure NYHA class 2 or above, prior or current cardiomyopathy,
             myocardial infarction within 6 months or angina requiring nitrate therapy more than
             once a week.

          -  Previous treatment with EGFR, ras, raf or MEK inhibitors.

          -  Inability to swallow capsules, refractory nausea and vomiting, chronic
             gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel
             resection that would preclude adequate absorption.

          -  Taking medication that significantly induces or inhibits CYP3A4.