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

NCT ID: NCT00694356

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-04
• Study Completion Date: 2009-04-28

Brief Summary

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

Conditions

Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dalotuzumab 5 mg/kg

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.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: BIOLOGICAL

IV infusion

Dalotuzumab 10 mg/kg

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.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: BIOLOGICAL

IV infusion

Dalotuzumab 15 mg/kg/7.5 mg/kg

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.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: BIOLOGICAL

IV infusion

Interventions

Dalotuzumab

IV infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-0646

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2008_012

Identifier Type: OTHER

Identifier Source: secondary_id

0646-009

Identifier Type: -

Identifier Source: org_study_id