Trial Information
An Open-Label, Dose Escalation Phase I Trial of MK0646 Given as a Weekly, Every Other Week, or Every Three Week Infusion in Patients With Advanced Solid Tumors and Multiple Myeloma
Trial Duration of Treatment: Subjects can be treated for up to one year if their disease has
not progressed and they are not having unmanageable side effects.
Inclusion Criteria:
- Patient has metastatic or locally advanced solid tumor or multiple myeloma
- Tumor specimen has IGF-1R expression
- Patient agrees to use birth control throughout study
Exclusion Criteria:
- Patient must not be recovering from antineoplastic therapy in the last 4 weeks
- Patient has participated in a clinical trial in the last 4 weeks
- Patient has a history of heart problems such as CHF, angina, heart attack or stroke
in the last 3 months
- Patient is taking growth hormone or growth hormone inhibitors
- If female, patient is pregnant or breastfeeding
- Patient is HIV positive
- Patient has a history of hepatitis B or C
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability as assessed by incidence of dose limiting toxicities (DLTs)
Outcome Time Frame:
throughout study
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Spain: Ministry of Health
Study ID:
2007_660
NCT ID:
NCT00701103
Start Date:
January 2006
Completion Date:
December 2009
Related Keywords:
- Solid Tumor
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasms