Overview

A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
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 of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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