Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	U3 Pharma AG
Information provided by:	U3 Pharma AG
ClinicalTrials.gov Identifier:	NCT00730470

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Immunoglobulins Globulin, Immune Epidermal Growth Factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by U3 Pharma AG:

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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) 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

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

Locations

United States, Michigan
Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Patricia LoRusso, MD 313-576-8749 lorussop@karmanos.org
United States, Tennessee
Vanderbilt Ingram cancer Centre	Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Mace Rothenberg, MD 615-322-4967 mace.rothenberg@Vanderbilt.Edu
United States, Washington
Northwest Medical Specialties	Recruiting
Tacoma, Washington, United States, 98405
Contact: Lorrin Yee, MD 253-428-8756 lyee@nwmsonline.com

Sponsors and Collaborators

U3 Pharma AG

More Information

Responsible Party:	U3 Pharma AG ( Dr Alan Boyd MD )
Study ID Numbers:	U3P1287/01
Study First Received:	August 7, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00730470
Health Authority:	United States: Food and Drug Administration

Keywords provided by U3 Pharma AG:

Human Epidermal Growth Factor Receptor 3
HER3
Heregulin

erb B3
Solid Tumors
Phase I Clinical Study

Study placed in the following topic categories:

Antibodies, Monoclonal
Signs and Symptoms
Antibodies
Immunoglobulins

ClinicalTrials.gov processed this record on January 16, 2009