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

This study has been completed.
Sponsor:
Information provided by:
U3 Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00730470
First received: August 7, 2008
Last updated: July 28, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: U3-1287 (AMG888)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by U3 Pharma GmbH:

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

Secondary Outcome Measures:
  • Pharmacokinetic Parameters [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic Parameters [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
  • Human anti-human antibody profile for U3-1287(AMG888) [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: U3-1287 (AMG888)
IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730470

Locations
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
  More Information

No publications provided by U3 Pharma GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Alan Boyd MD, U3 Pharma GmbH
ClinicalTrials.gov Identifier: NCT00730470     History of Changes
Other Study ID Numbers: U3P1287/01
Study First Received: August 7, 2008
Last Updated: July 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by U3 Pharma GmbH:
Human Epidermal Growth Factor Receptor 3
HER3
Heregulin
erb B3
Solid Tumors
Phase I Clinical Study

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014