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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors

Outcome Time Frame:

Lenth of study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

U3P1287/01

NCT ID:

NCT00730470

Start Date:

August 2008

Completion Date:

July 2010

Related Keywords:

  • Advanced Solid Tumors
  • Human Epidermal Growth Factor Receptor 3
  • HER3
  • Heregulin
  • erb B3
  • Solid Tumors
  • Phase I Clinical Study
  • Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Northwest Medical SpecialtiesTacoma, Washington  98405
Karmanos Cancer InstituteDetroit, Michigan  48201
Dana Faber Cancer InstituteBoston, Massachusetts  02115
Memorial Sloan-Kettering Cancer CentreNew York, New York  10021
Vanderbilt Ingram cancer CentreNashville, Tennessee  37232