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Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer


Phase 1
19 Years
N/A
Not Enrolling
Both
Ovarian Cancer, Colorectal Cancer

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Trial Information

Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI

Outcome Time Frame:

up to 19.5 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:

BP22909

NCT ID:

NCT01148758

Start Date:

May 2010

Completion Date:

August 2010

Related Keywords:

  • Ovarian Cancer, Colorectal Cancer
  • Colorectal Neoplasms
  • Ovarian Neoplasms

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