Status:
COMPLETED
Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors
Lead Sponsor:
U3 Pharma GmbH
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00730470
Start Date
August 1 2008
End Date
July 1 2010
Last Update
July 29 2010
Active Locations (6)
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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