NCT00730470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 29, 2010

Status Verified

July 1, 2010

Enrollment Period

1.9 years

First QC Date

August 7, 2008

Last Update Submit

July 28, 2010

Conditions

Advanced Solid Tumors

Keywords

Human Epidermal Growth Factor Receptor 3HER3Heregulinerb B3Solid TumorsPhase I Clinical Study

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Pharmacokinetic Parameters

    Length of study

  • Pharmacodynamic Parameters

    Length of study

  • Human anti-human antibody profile for U3-1287(AMG888)

    Length of study

Study Arms (1)

1

EXPERIMENTAL
Drug: U3-1287 (AMG888)

Interventions

U3-1287 (AMG888)DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dana Faber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Memorial Sloan-Kettering Cancer Centre

New York, New York, 10065, United States

Location

Vanderbilt Ingram cancer Centre

Nashville, Tennessee, 37232, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

  • LoRusso P, Janne PA, Oliveira M, Rizvi N, Malburg L, Keedy V, Yee L, Copigneaux C, Hettmann T, Wu CY, Ang A, Halim AB, Beckman RA, Beaupre D, Berlin J. Phase I study of U3-1287, a fully human anti-HER3 monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2013 Jun 1;19(11):3078-87. doi: 10.1158/1078-0432.CCR-12-3051. Epub 2013 Apr 16.

    PMID: 23591447DERIVED

MeSH Terms

Conditions

Lethal Congenital Contracture Syndrome 2Fibromatosis, Gingival, 2

Interventions

patritumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 8, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 29, 2010

Record last verified: 2010-07

Locations

US(6)