A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs capecitabine (Xeloda) in Patients with Colorectal Cancer who have Failed One Or Two Prior Chemotherapeutic Regimens.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

1.Have histologically confirmed colorectal cancer
2.Require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan. Prior surgery and/or localised irradiation are allowed.
3.Have WHO performance status (PS) 0-2 and life expectancy > 12 weeks
4.Be suitable for treatment with capecitabine
5.Be aged at least 18 years
6.Provide written informed consent to participate in the study

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

Exclusion Criteria

1.Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine monotherapy. (Prior capecitabine therapy will be allowed if part of a combination regimen).
2.Any recent surgery, unhealed surgical incision or severe concomitant condition (eg, uncontrolled cardiac disease) which, in the Investigator’s opinion, makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the study protocol.
3.Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that, in the investigator’s judgement, would preclude adequate absorption.
4.Current or prior malignancy within previous 3 years (other than colorectal cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix).
5.Brain metastases or spinal cord compression unless treated and stable off steroids for one month.
6.Any unresolved toxicity >CTC grade 2 from previous anticancer therapy.
7.Planned palliative radiotherapy. Less than 2 weeks since completion of prior radiotherapy or persistence of any acute radiotherapy toxicity.
8.Corrected baseline mean QT measurement (QTc) > 450ms.
9.Patients with factors that increase risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, family history of long QT syndrome or any concomitant medication known to prolong QTc.
10.Any of the following laboratory values:
·Total bilirubin = 1.5 x ULN
·ALT or AST = 2.5 x ULN irrespective of whether liver metastases present
11.Any of the following laboratory values:
·Platelets < 100 x10 to the power 9 /l (100,000/mm3)
·Haemoglobin < 10g/dl despite transfusion
·Absolute neutrophil count (ANC) < 1.5 x10 to the power 9 /l (1,500/mm3)
12.Calculated serum creatinine clearance = 50 ml/min (using Cockcroft-Gault formula) and/or an elevated serum creatinine = 1.25 ULN.
13.Presence of clinically significant blood or protein on repeat urine labstix test.
14.History of hypersensitivity to active or inactive excipients of any study medication (AZD6244, capecitabine, Captisol).
15.Pregnancy or breast feeding or women of child bearing potential not using an effective method of birth control.
16.Previous enrolment and randomisation to treatment in the present study.
17.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).

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

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