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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Multiple Myeloma

Treatments: Drug: Dalotuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701103

2007_660 (Other Identifier)

0646-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 11 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab

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

Experimental group

Description:

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

Treatment:

Drug: Dalotuzumab