Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Neoplasm

Treatments: Biological: Dalotuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694356

0646-009

2008_012 (Other Identifier)

Details and patient eligibility

About

This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or metastatic solid tumors using once weekly and once every other week dose infusion regimens.

The primary study hypothesis is that administration of dalotuzumab as a once weekly and an every other week infusion will be generally safe and well tolerated

Enrollment: 15 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has histologically- or cytologically-confirmed metastatic or locally advanced solid tumor(s) that has (have) failed to respond to standard therapy, or for which adequate standard therapy does not exist
• Has tumor(s) associated with insulin-like growth factor 1 receptor (IGF-1R) expression in the literature (e.g. prostate, pancreatic, colon, lung and breast)
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Demonstrates adequate organ function

Exclusion criteria

• Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
• Is concurrently using growth hormone (GH), or growth hormone inhibitor
• Has any active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has any primary CNS tumor - any symptomatic ascites or plural effusion
• Has a history or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the participant's participation, or pose an additional risk to the participant
• Is pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Dalotuzumab 5 mg/kg

Experimental group

Description:

Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.

Treatment:

Biological: Dalotuzumab

Dalotuzumab 10 mg/kg

Experimental group

Description:

Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.

Treatment:

Biological: Dalotuzumab

Dalotuzumab 15 mg/kg/7.5 mg/kg

Experimental group

Description:

Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.

Treatment:

Biological: Dalotuzumab