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

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01358903

First received: May 18, 2011

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 18, 2011

Last Updated Date

May 7, 2013

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Arm A: Pharmacokinetics (serum levels of RO5429083) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
Arm A: Safety (Incidence of adverse events related to study drug) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
Arm A: Maximum tolerated dose of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
Arm A: Tumor Growth Control Rate [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01358903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Arm A: Recommended dose of RO5429083 for the extension cohort [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
Arm A: Anti-tumor activity of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
Arm B: Target saturation of 89Zr-labelled RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: RO5429083
Cohorts receiving multiple escalating doses iv
Drug: RO5429083
Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Study Arm (s)

Experimental: A
Intervention: Drug: RO5429083
Experimental: B
Intervention: Drug: RO5429083

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: BP25385 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States, France, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01358903

Other Study ID Numbers ^ICMJE

BP25385, 2010-021168-13

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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