Status:
COMPLETED
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment p...
Detailed Description
The study consisted of 3 parts. In Part 1 the loading dose was escalated while the maintenance dose was kept constant. In Part 2 the loading dose was kept constant while the maintenance dose was escal...
Eligibility Criteria
Inclusion
- Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function
Exclusion
- Participant is using growth hormones or growth hormone inhibitors
- Participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy
- Participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
- Participant has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a participant who has completed a course of therapy and is clinically stable may be able to participate
- Participant is pregnant or breastfeeding
- Participant is human immunodeficiency virus (HIV) positive
- Participant has a history of Hepatitis B or C
- Participant has symptomatic ascites or pleural effusion. However, if the participant has received treatment and is stable, they may be able to participate
- Female participant plans to become pregnant or a male participant who plans to impregnate their partner during the time the study is ongoing
Key Trial Info
Start Date :
August 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00635778
Start Date
August 7 2006
End Date
November 5 2008
Last Update
October 9 2018
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