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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: U3-1287 (AMG888)

• Registration Number: NCT00730470
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-28
• Last Update Posted: 2010-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	U3-1287 (AMG888)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors	Lenth of study
To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors	Lenth of study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters	Length of study
Pharmacodynamic Parameters	Length of study
Human anti-human antibody profile for U3-1287(AMG888)	Length of study

Trial Locations

Locations (6)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Faber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Centre; 🇺🇸 New York, New York, United States

Northwest Medical Specialties; 🇺🇸 Tacoma, Washington, United States

Vanderbilt Ingram cancer Centre; 🇺🇸 Nashville, Tennessee, United States