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
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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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2011-06-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
RO5429083
Cohorts receiving multiple escalating doses iv
B
RO5429083
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
RO5429083
Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Houston, Texas, United States
Seattle, Washington, United States
Paris, , France
Toulouse, , France
Amsterdam, , Netherlands
Nijmegen, , Netherlands
Countries
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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