A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

NCT ID: NCT01358903

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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-03-31

Brief Summary

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This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

RO5429083

Intervention Type DRUG

Cohorts receiving multiple escalating doses iv

B

Group Type EXPERIMENTAL

RO5429083

Intervention Type DRUG

Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Interventions

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RO5429083

Cohorts receiving multiple escalating doses iv

Intervention Type DRUG

RO5429083

Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Metastatic and/or locally advanced malignant CD44-expressing solid tumors
* Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
* Life expectancy of over 12 weeks

Exclusion Criteria

* Concurrent therapy with any other investigational drug
* Known or suspected CNS metastases including leptomeningeal metastases
* Active bleeding, bleeding diathesis or history of coagulation disorder
* Uncontrolled diabetes mellitus
* Active or uncontrolled infections
* Patients with HIV infections
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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Houston, Texas, United States

Site Status

Seattle, Washington, United States

Site Status

Paris, , France

Site Status

Toulouse, , France

Site Status

Amsterdam, , Netherlands

Site Status

Nijmegen, , Netherlands

Site Status

Countries

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United States France Netherlands

Other Identifiers

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2010-021168-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP25385

Identifier Type: -

Identifier Source: org_study_id