A Study of RO5458640 in Patients With Advanced Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01383733
• Date of registration: 27/06/2011
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RO5458640 in Patients With Advanced Solid Tumors
• Scientific 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
• Date of first enrolment: July 2011
• Target sample size: 54
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01383733
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada, Denmark, Netherlands

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasms

Intervention(s)

Drug: RO5458640

Primary Outcome(s)

Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0 [Time Frame: approximately 2 years]

Maximum Tolerated Dose (MTD) [Time Frame: approximately 2 years]

Safety: Incidence of adverse events [Time Frame: approximately 2 years]

Secondary Outcome(s)

Antigenicity: Human anti-human antibody [HAHA] profile [Time Frame: approximately 2 years]

Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules [Time Frame: approximately 2 years]

Tumor response according to RECIST criteria [Time Frame: approximately 2 years]

Secondary ID(s)

NP25448

Source(s) of Monetary Support

Please refer to primary and secondary sponsors