A Study of RO5458640 in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: RO5458640

• Registration Number: NCT01383733
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or unacceptable toxicity occurs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Histologically or cytologically confirmed malignant solid tumors
• Measurable and/or evaluable disease according to RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate bone marrow, liver and renal function

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Exclusion Criteria

• Prior chemotherapy, radiotherapy, or hormonal therapy for cancer within 3 weeks of first study treatment, except for short course palliative radiotherapy for pain
• Antibody therapy or other immunotherapy currently or less than 21 days prior to study treatment
• Current immunosuppressive therapy, including those prescribed for organ transplantation and rheumatologic disease
• Corticoid therapy > 10 mg/day prednisone or equivalent
• Patients who have not recovered from > grade 1 (NCI CTCAE) prior adverse events from any cancer therapy, except for alopecia
• Pregnant or breastfeeding women
• Known hypersensitivity to any component of RO5458640 or previous severe hypersensitivity reactions to monoclonal antibody therapy
• History of active seizure disorder
• History of CNS or leptomeningeal metastases, except for clinically stable disease for at least 3 weeks prior to first study drug
• Cardiovascular illness: CVA or MI < 6 months prior to study, CHF > NYHA Class 2, QTcF >480 msec.
• Active infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	RO5458640	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 2 years
Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0	approximately 2 years
Maximum Tolerated Dose (MTD)	approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Tumor response according to RECIST criteria	approximately 2 years
Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules	approximately 2 years
Antigenicity: Human anti-human antibody [HAHA] profile	approximately 2 years