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

NCT00694356 | Completed Phase 1 Results

• 2 other identifiers: 0646-0092008_012
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)

  Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever \>38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented.

  Cycle 1 (Up to 4 weeks)

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.

  Up to 30 days after last dose of study treatment (Up to 101 days)

• Number of Participants Who Discontinued Study Treatment Due to an AE

  An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.

  Up to 71 days

Secondary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of Dalotuzumab

  Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose

• Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab

  Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose

• Time to Cmax (Tmax) of Dalotuzumab

  Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose

• Apparent Terminal Half-life (t1/2) of Dalotuzumab

  Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose

• Clearance (CL) of Dalotuzumab

  Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose

Study Arms (3)

Dalotuzumab 5 mg/kg

EXPERIMENTAL

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.

Biological: Dalotuzumab

Dalotuzumab 10 mg/kg

EXPERIMENTAL

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.

Biological: Dalotuzumab

Dalotuzumab 15 mg/kg/7.5 mg/kg

EXPERIMENTAL

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.

Biological: Dalotuzumab

Interventions

Dalotuzumab BIOLOGICAL

IV infusion

Also known as: MK-0646

Dalotuzumab 10 mg/kg; Dalotuzumab 15 mg/kg/7.5 mg/kg; Dalotuzumab 5 mg/kg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms

Interventions

dalotuzumab

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 10, 2008
• Study Start: August 4, 2008
• Primary Completion: March 18, 2009
• Study Completion: April 28, 2009
• Last Updated: August 8, 2018
• Results First Posted: June 15, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share