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A Double Blind Randomised Phase 2 Trial of Docetaxel With or Without AZD6244 in wt BRAF Advanced Melanoma

Phase 2
16 Years
Open (Enrolling)

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Trial Information

A Double Blind Randomised Phase 2 Trial of Docetaxel With or Without AZD6244 in wt BRAF Advanced Melanoma

No further information in addition to what has been provided in the brief summary

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

To assess the efficacy of AZD6244 in combination with docetaxel, compared with docetaxel alone, in first line patients with wild type BRAF advanced malignant melanoma

Outcome Time Frame:

Analysis will be performed when approximately 58 disease progression/death events have occurred. Average time 7 months.

Safety Issue:


Principal Investigator

Mark R Middleton

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oxford


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

October 2010

Completion Date:

October 2015

Related Keywords:

  • Melanoma
  • Melanoma