Status:
TERMINATED
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard ...
Eligibility Criteria
Inclusion
- Be willing and able to provide written informed consent for the study.
- Be ±18 years of age of either sex and of any race/ethnicity;
- Part 1: Have a histologically or cytologically confirmed advanced malignant solid tumor;
- Part 2: Have a histologically or cytologically confirmed, with measurable disease (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]), advanced, malignant solid tumor.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of \<=2.
- Have adequate organ function within 3 weeks prior to first study drug administration.
Exclusion
- Not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion.
- Not have a history of another malignancy
- Not have received prior therapy with any anti-insulin-like growth factor receptor 1 (anti-IGF-1R) monoclonal antibody.
- Not have received radiation therapy within 2 weeks prior to first study drug administration.
- Not have received radiation therapy to \>25% of his/her total bone marrow during his/her lifetime.
- Not have undergone major surgery within 3 weeks prior to first study drug administration.
- Not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy.
- Not have known active hepatitis B or C.
- Not have any serious or uncontrolled infection.
- Not have uncontrolled diabetes mellitus.
- Not have had any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.
Key Trial Info
Start Date :
September 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00954512
Start Date
September 25 2009
End Date
June 7 2011
Last Update
August 24 2018
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