A Study of RO5458640 in Patients With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title:

A Phase I Multiple Ascending Dose (MAD) Study of RO5458640, a Humanized Monoclonal Antibody Against the TNF-like Weak Inducer of Apoptosis (TWEAK) Ligand, in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383733
• Other study ID #: NP25448
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2011
• Last updated: November 1, 2016
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RO5458640
Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Canada,  Denmark,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 2 years	No
Primary	Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0		approximately 2 years	No
Primary	Maximum Tolerated Dose (MTD)		approximately 2 years	No
Secondary	Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules		approximately 2 years	No
Secondary	Tumor response according to RECIST criteria		approximately 2 years	No
Secondary	Antigenicity: Human anti-human antibody [HAHA] profile		approximately 2 years	No