A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Docetaxel, Compared with Docetaxel Alone, in 2nd Line Patients with KRAS Mutation Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB ? IV) - ND
- Conditions
- 2nd Line Patients with KRAS Mutation Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB?IV)MedDRA version: 9.1Level: PTClassification code 10029521MedDRA version: 9.1Level: LLTClassification code 10029522MedDRA version: 9.1Level: PTClassification code 10059515
- Registration Number
- EUCTR2008-006323-31-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Provision of signed, written and dated informed consent prior to any study specific procedures 2. Male or female, aged 18 years or older 3. Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV) 4.Failure of 1st line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following 1st line therapy. See Appendix L for further details. See Section 5.2 for specific 1st line agents not permitted in this study. 5. WHO Performance Status 0 ? 1 6. Patients must be eligible to receive treatment with docetaxel in accordance with docetaxel product information (available from Sanofi-Aventis, the manufacturer of docetaxel ? see Appendix J for contact details) 7. At least one lesion, not previously irradiated, that can be accurately measured as ≥10 mm in the longest diameter (LD) with spiral computed tomography (CT) scan or as ≥20 mm with conventional techniques (conventional CT, MRI) and which is suitable for accurate repeated measurements 8. Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using a) allele specific PCR (this includes ARMS?) or b) direct sequencing) 9. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Post menopausal females are defined as follows: natural menopause with menses >1 year ago; or radiation-induced oophorectomy with last menses >1 year ago; or chemotherapy-induced menopause with 1 year interval since last menses; or serum FSH and LH and plasma oestradiol levels in the postmenopausal range for the institution; or bilateral oopherectomy or hysterectomy. 10. Serum creatinine clearance >50mL/min by either Cockcroft-Gault formula or 24hr urine collection analysis 11. Patients should be able to swallow AZD6244/placebo capsules.
Are the trial subjects under 18? no
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
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous randomisation of treatment in the present study 3. Mixed small cell and non-small cell lung cancer histology 4. Received >1 prior anti-cancer therapy for advanced or metastatic NSCLC (excluding radiotherapy, see exclusions 6 and 9) 5. Having received an investigational drug within the 30 days prior to entry, or have not recovered from side effects of an investigational drug 6. Receiving or have received systemic anti-cancer therapy within 4 weeks prior to starting study treatment (6 weeks for nitrosoureas, mitomycin, and suramin) 7. Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable) 8. Any unresolved toxicity >CTCAE Grade 2 from previous anti-cancer therapy, apart from alopecia 9. The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 2 weeks of the first dose of study treatment 10. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method