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A Study of RO5458640 in Patients With Advanced Solid Tumors

NCT ID: NCT01383733

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-03-31

Brief Summary

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This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or unacceptable toxicity occurs.

Detailed Description

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Conditions

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Neoplasms

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

RO5458640

Intervention Type DRUG

Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks

Interventions

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RO5458640

Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed malignant solid tumors
* Measurable and/or evaluable disease according to RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow, liver and renal function

Exclusion Criteria

* Prior chemotherapy, radiotherapy, or hormonal therapy for cancer within 3 weeks of first study treatment, except for short course palliative radiotherapy for pain
* Antibody therapy or other immunotherapy currently or less than 21 days prior to study treatment
* Current immunosuppressive therapy, including those prescribed for organ transplantation and rheumatologic disease
* Corticoid therapy \> 10 mg/day prednisone or equivalent
* Patients who have not recovered from \> grade 1 (NCI CTCAE) prior adverse events from any cancer therapy, except for alopecia
* Pregnant or breastfeeding women
* Known hypersensitivity to any component of RO5458640 or previous severe hypersensitivity reactions to monoclonal antibody therapy
* History of active seizure disorder
* History of CNS or leptomeningeal metastases, except for clinically stable disease for at least 3 weeks prior to first study drug
* Cardiovascular illness: CVA or MI \< 6 months prior to study, CHF \> NYHA Class 2, QTcF \>480 msec.
* Active infection
Minimum Eligible Age

18 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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Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

København Ø, , Denmark

Site Status

Amsterdam, , Netherlands

Site Status

Countries

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Canada Denmark Netherlands

Other Identifiers

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NP25448

Identifier Type: -

Identifier Source: org_study_id