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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies; Capecitabine; Pertuzumab

Criteria

Inclusion Criteria:

• Adults at least 18 years of age

• Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy at least 12 weeks

• Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which has progressed during/after standard therapy

• Human epidermal growth factor receptor 2 (HER2)-negative among participants with breast cancer

• Negative pregnancy test or use of an adequate contraceptive method among women of childbearing potential

• Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

• Clinical evidence of central nervous system (CNS) metastases

• Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy within 2 weeks of study Day 1

• History of palmar plantar syndrome Grade 2 or worse, or any unresolved residual chemotherapy effects

• Prior HER2-active agents, continuous intravenous (IV) 5-fluorouracil, capecitabine, or other fluoropyrimidine

• Any investigational agent within 28 days of study start

• Prior cumulative doxorubicin dose greater than (>) 360 mg/m^2 or equivalent

• Significant cardiovascular disease

• Active/uncontrolled concurrent illness or infection-

• Major surgery or trauma within 4 weeks of study Day 1