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

Sponsor

U3 Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00730470

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: U3-1287 (AMG888)

IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients

Outcome Measures

Primary Outcome Measures

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

Pharmacokinetic Parameters [Length of study]
Pharmacodynamic Parameters [Length of study]
Human anti-human antibody profile for U3-1287(AMG888) [Length of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Dana Faber Cancer Institute	Boston	Massachusetts	United States	02115
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02115
3	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
4	Memorial Sloan-Kettering Cancer Centre	New York	New York	United States	10065
5	Vanderbilt Ingram cancer Centre	Nashville	Tennessee	United States	37232
6	Northwest Medical Specialties	Tacoma	Washington	United States	98405