Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730470
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : July 29, 2010
Information provided by:
U3 Pharma GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: U3-1287 (AMG888) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: 1 Drug: U3-1287 (AMG888)
IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors [ Time Frame: Lenth of study ]
  2. To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors [ Time Frame: Lenth of study ]

Secondary Outcome Measures :
  1. Pharmacokinetic Parameters [ Time Frame: Length of study ]
  2. Pharmacodynamic Parameters [ Time Frame: Length of study ]
  3. Human anti-human antibody profile for U3-1287(AMG888) [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730470

United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Centre
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt Ingram cancer Centre
Nashville, Tennessee, United States, 37232
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
U3 Pharma GmbH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Alan Boyd MD, U3 Pharma GmbH Identifier: NCT00730470     History of Changes
Other Study ID Numbers: U3P1287/01
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010

Keywords provided by U3 Pharma GmbH:
Human Epidermal Growth Factor Receptor 3
erb B3
Solid Tumors
Phase I Clinical Study