Status:
COMPLETED
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer, Ovarian Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts...
Eligibility Criteria
Inclusion
- adult patients, \>/=19 years of age
- metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
- presence of tumor lesions suitable for DCE-MRI evaluation
- WHO performance status 0-1
- adequate bone marrow, liver and renal function
Exclusion
- patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
- brain metastases
- clinically significant ascites
- active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
- radiation therapy within 3 weeks, or anti-neoplastic therapy \<30 days prior to first dose of study drug
- chronic therapy with systemic steroids or another immunosuppressive agent \<2 weeks prior to first dose of study drug
- treated with bevacizumab in last regimen of systemic therapy
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01148758
Start Date
May 1 2010
End Date
September 1 2010
Last Update
November 2 2016
Active Locations (3)
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1
Leuven, Belgium, 3000
2
Barcelona, Barcelona, Spain, 08035
3
Manchester, United Kingdom, M20 4QL