Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT01256359
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01256359
Study Brief:
Protocol Section:
NCT01256359