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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: RO5429083

• Registration Number: NCT01358903
• Lead Sponsor: Hoffmann-La Roche

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 available

Study Timeline

• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-24
• Study Start: 2011-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	RO5429083	-
B	RO5429083	-

Primary Outcome Measures

Name	Time	Method
Arm A: Safety (Incidence of adverse events related to study drug)	Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Maximum tolerated dose of RO5429083	Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)	Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Tumor Growth Control Rate	Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Pharmacokinetics (serum levels of RO5429083)	Until disease progression or unacceptable toxicity (approximately 2 years)

Secondary Outcome Measures

Name	Time	Method
Arm A: Recommended dose of RO5429083 for the extension cohort	Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Anti-tumor activity of RO5429083	Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Target saturation of 89Zr-labelled RO5429083	Until disease progression or unacceptable toxicity (approximately 2 years)