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NCT Number: NCT01383733

A Study of RO5458640 in Patients With Advanced Solid Tumors

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5458640

Drug

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

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 2 years

  2. Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0

    Time frame: approximately 2 years

  3. Maximum Tolerated Dose (MTD)

    Time frame: approximately 2 years

Secondary outcomes

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

    Time frame: approximately 2 years

  2. Tumor response according to RECIST criteria

    Time frame: approximately 2 years

  3. Antigenicity: Human anti-human antibody [HAHA] profile

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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