A Study of RO5458640 in Patients With Advanced Solid Tumors

NCT01383733 | Completed Phase 1

• 1 other identifier: NP25448
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 4

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules

  approximately 2 years

• Tumor response according to RECIST criteria

  approximately 2 years

• Antigenicity: Human anti-human antibody [HAHA] profile

  approximately 2 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: RO5458640

Interventions

RO5458640 DRUG

Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Ottawa, Ontario, K1H 8L6, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

København Ø, 2100, Denmark

Location

Unknown Facility

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (2); DK (1); NL (1)