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

NCT ID: NCT01148758

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer, Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

RO5323441

Intervention Type DRUG

cohorts receiving multiple doses iv

Interventions

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RO5323441

cohorts receiving multiple doses iv

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Leuven, , Belgium

Site Status

Barcelona, Barcelona, Spain

Site Status

Manchester, , United Kingdom

Site Status

Countries

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Belgium Spain United Kingdom

Other Identifiers

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2009-016014-25

Identifier Type: -

Identifier Source: secondary_id

BP22909

Identifier Type: -

Identifier Source: org_study_id