NCT02494596View on ClinicalTrials.gov

A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

September 30, 2005

Study Completion Date

September 30, 2005

Conditions

Solid Tumor

Interventions

DRUG

Capecitabine

Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m\^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

DRUG

RhuMab 2C4

Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 1050 mg via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

Trial Locations (2)

08036

Barcelona

M20 4BX

Manchester

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY

NCT02494596 - A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter