Status:
COMPLETED
MEK Inhibitor and Thoracic Radiotherapy Trial
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
AstraZeneca
University of Manchester
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Two thirds of non small cell lung cancer patients present with locally advanced tumours (stage III) or metastatic disease (stage IV) and radiotherapy plays a major role in their treatment. Treatment (...
Detailed Description
As above
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC either inoperable, stage III NSCLC or stage IV NSCLC with dominant chest symptoms.
- Patient age ≥18
- Willingness and able to comply with treatment, tests and attend the required follow-up
- Prior chemotherapy is permitted provided the interval between day 8 of the last cycle of chemotherapy and day 1 of AZD6244 dosing is ≥2 weeks
- No prior radiotherapy or investigational agents
- Life expectancy estimated to be greater than 3 months
- Performance status(ECOG) 0 or 1
- MRC dyspnoea score \<3
- Patient considered able to tolerate radical radiotherapy
- FEV1 \>40% of predicted and DLCO (transfer factor for carbon monoxide) \>40% of predicted
- Disease which can be encompassed within a radical radiotherapy treatment volume(V20 ≤35% and maximum cord dose 48Gy) on the radiotherapy planning scan
- Left ventricular ejection fraction \>50% on baseline echocardiogram
- Adequate renal function - defined by GFR \>50 ml/min (calculated Cockcroft and Gault) or by isotope GFR.
- Adequate bone marrow reserve: white cell count \>3 x 109/l, absolute neutrophil count \>1.5 x 109/l, haemoglobin \>10.0 g/dl and platelet count \>100 x 109/l (Blood transfusion permitted to achieve Hb \>10g/dl)
- AST/ALT \< 2.5 ULN and bilirubin \<1.5 ULN
- Group D (expanded cohort) only: diameter of the primary tumour should be \> 2 cm
Exclusion
- Mixed non-small cell and small cell tumours
- Other previous or current malignant disease likely to interfere with protocol treatment or comparisons
- Lack of recovery from prior chemotherapy toxicity to grade ≤2 except alopecia d)Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption of AZD6244
- Presence of clinically significant fluid accumulations in third spaces which cannot be adequately controlled by drainage or other procedures prior to inclusion in the study.
- History / evidence of active bleeding diatheses
- History of unstable diabetes
- History of interstitial pneumonitis
- Arterial hypertension defined as SBP≥ 160 or DBP ≥100 (antihypertensive medication to achieve these parameters are permissible)
- Myocardial infarction, or unstable or uncontrolled angina, congestive heart failure (NYHA \> class II) within 1 year of enrollment
- Active infection on day of enrollment
- Uncontrolled hypercalcemia \>3.0 or symptomatic
- History of hypersensitivity to active or inactive excipients of AZD6244
- 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
- Known and symptomatic brain metastases. Brain imaging is not mandatory if patient is asymptomatic.
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients of reproductive potential who are unable to comply with effective contraception if sexually active during the study and for a period of at least 90 days (men) or 6 months after treatment (women)
- Women who are breastfeeding
Key Trial Info
Start Date :
June 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01146756
Start Date
June 4 2010
End Date
February 8 2017
Last Update
February 15 2023
Active Locations (1)
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1
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX