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A Study of RO5458640 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01383733
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: RO5458640 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: Single Arm Drug: RO5458640
Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01383733

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Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
København Ø, Denmark, 2100
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01383733    
Other Study ID Numbers: NP25448
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016