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

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: RO5429083

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358903

BP25385

2010-021168-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: RO5429083

Drug: RO5429083

B

Experimental group

Treatment:

Drug: RO5429083

Drug: RO5429083