Trial | NCT00730470  Report issue

Title

Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors
A Phase I, Open-label, Dose-Finding Study to Assess the Safety and Tolerability of U3-1287 (AMG 888), a Human Monoclonal Antibody Targeting HER3 in Patients With Advanced Solid Tumors.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    patritumab ...

  • Study Participants

    60
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.
Study Started
Aug 31
2008
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
Jul 29
2010
Estimate

Drug U3-1287 (AMG888)

IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients

1 Experimental

Criteria 

Key Inclusion Criteria:

Pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Men or women at least 18 years of age
Adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function

Key Exclusion Criteria:

Presence of untreated or symptomatic brain metastasis.
Presence of ascites or pleural effusion requiring chronic medical intervention.
Uncontrolled hypertension
Concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis.
Recent major surgical procedure or not yet recovered from major surgery
Recent participation in clinical drug trials.
Participation in other investigational procedures.
Unresolved toxicities from prior anti-cancer therapy
Patient who is pregnant (e.g. positive human choriogonadotropin [HCG] test) or nursing.
No Results Posted