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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 2 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

NP25448

NCT ID:

NCT01383733

Start Date:

July 2011

Completion Date:

March 2013

Related Keywords:

  • Neoplasms
  • Neoplasms

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