Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)

NCT ID: NCT00701103

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-12
• Study Completion Date: 2009-12-01

Brief Summary

This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.

The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.

Detailed Description

Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.

Conditions

Solid Tumor; Multiple Myeloma

Study Design

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

Study Groups

Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 5 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 10 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 10 mg/kg Q1W (20 mg/mL)

Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 15 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 15 mg/kg Q1W (20 mg/mL)

Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 20 mg/kg Q1W (10 mg/mL)

Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 20 mg/kg Q1W (20 mg/mL)

Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 20 mg/kg Q2W (20 mg/mL)

Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Dalotuzumab 30 mg/kg Q3W (20 mg/mL)

Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion1 time every 3 weeks (Q3W).

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

IV infusion

Interventions

Dalotuzumab

IV infusion

Intervention Type: DRUG

Other Intervention Names

MK-0646

Eligibility Criteria

Inclusion Criteria

• Participant has metastatic or locally advanced solid tumor or multiple myeloma
• Tumor specimen has IGF-1R expression
• Participant agrees to use birth control throughout study

Exclusion Criteria

• Participant must not be recovering from antineoplastic therapy in the last 4 weeks
• Participant has participated in a clinical trial in the last 4 weeks
• Participant has a history of heart problems such as congestive heart failure, angina, heart attack or stroke in the last 3 months
• Participant is taking growth hormone or growth hormone inhibitors
• If female, participant is pregnant or breastfeeding
• Participant is human immunodeficiency virus (HIV) positive
• Participant has a history of hepatitis B or C

• Minimum Eligible Age: 18 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

References

Atzori F, Tabernero J, Cervantes A, Prudkin L, Andreu J, Rodriguez-Braun E, Domingo A, Guijarro J, Gamez C, Rodon J, Di Cosimo S, Brown H, Clark J, Hardwick JS, Beckman RA, Hanley WD, Hsu K, Calvo E, Rosello S, Langdon RB, Baselga J. A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2011 Oct 1;17(19):6304-12. doi: 10.1158/1078-0432.CCR-10-3336. Epub 2011 Aug 2.

Reference Type: RESULT

PMID: 21810918 (View on PubMed)

Other Identifiers

2007_660

Identifier Type: OTHER

Identifier Source: secondary_id

0646-001

Identifier Type: -

Identifier Source: org_study_id

NCT00282737

Identifier Type: -

Identifier Source: nct_alias