A multicenter phase II study to evaluate safety and efficacy of glutadon once weekly (GDO) in patients with metastatic colorectal cancer resistant or intolerable to approved chemo- and molecular-targeted therapies

ew Medical Enzymes AG0 sitesApril 30, 2010

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ew Medical Enzymes AG

•Age \= 18 years at visit 1 (day \-3\)
•Histologically confirmed diagnosis of colorectal cancer that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent
•Prior treatment with a fluoropyrimidine (5\-fluorouracil and/or capecitabine), oxaliplatin, irinotecan or documented intolerance or ineligibility to the drugs
•K\-RAS mutation or previous therapy with EGFR antagonists (e.g. cetuximab or panitumumab)
•At least one measurable site of disease on CT/MRI scan at screening
•ECOG Performance Status of 0 or 1
•Patients must have normal organ and marrow function:
•1\.White blood cell count (WBC) \= 3\.5x 109/L;
•2\.Platelets \= 100 x 109/L; Hb \> 9 g/dl
•3\.ALT and AST \= 2\.5 x upper limit of normal (ULN) or \= 5\.0 x ULN if considered due to tumor;

•Patients had \> 3 previous systemic therapies for metastatic disease
•Prior treatment with glutadon, PEG\-PGA or DON
•Known hypersensitivity to PEG\-PGA and/or DON
•Treatment with any cytotoxic and/or investigational cytotoxic drug \= 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1 (day \-3\)
•Previous malignancy (other than colorectal cancer) in the last 5 years except basal cell cancer of the skin, pre\-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1].
•Impaired cardiac function defined as congestive heart failure NYHA \> class II, any clinically significant brady\- or tachycardia, myocardial infarction within 12 months prior to Visit 1, or any other clinically significant heart disease (e.g., unstable angina or uncontrolled hypertension)
•Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
•Abnormal electrolyte (Serum sodium, potassium and calcium) values that are clinically significant in opinion of the investigator.
•Patients who have undergone major surgery \= 2 weeks prior to Visit 1 (day \-3\) or who have not recovered from side effects of such therapy
•Patients who have received wide field radiotherapy \= 4 weeks or limited field radiation for palliation \< 2 weeks prior to Visit 1 (day \-3\) or who have not recovered from side effects of such therapy