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

Advanced Solid Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730470
• Other study ID #: U3P1287/01
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2008
• Last updated: July 28, 2010
• Start date: August 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: U3 Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• U3-1287 (AMG888)
IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients

Locations

Country	Name	City	State
United States	Dana Faber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Vanderbilt Ingram cancer Centre	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Centre	New York	New York
United States	Northwest Medical Specialties	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
U3 Pharma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors		Lenth of study	Yes
Primary	To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors		Lenth of study	Yes
Secondary	Pharmacokinetic Parameters		Length of study	Yes
Secondary	Pharmacodynamic Parameters		Length of study	Yes
Secondary	Human anti-human antibody profile for U3-1287(AMG888)		Length of study	Yes