Phase I Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Participants With Colorectal Cancer (MK-0646-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Biological: Dalotuzumab 10 mg/kg; Drug: Irinotecan; Biological: Dalotuzumab 15/7.5 mg/kg; Biological: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00925015

0646-016

2009_602

Details and patient eligibility

About

The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is 20 years of Age or older
• Has a histologically or cytologically confirmed colorectal cancer
• Has previously failed both Irinotecan and Oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression as verified by previous radiologic scans
• Must have adequate organ function

Exclusion criteria

• Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to initial dosing on this study or whose toxicities from agents administrated 4 weeks earlier have not resolved to at least grade 1 or baseline
• Has experienced intolerable toxicity to Irinotecan therapy
• Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors (e.g. Cetuximab)
• Is concurrently using growth hormone (GH), Or GH inhibitors

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Cetux/Irin - Dmab 10 mg/kg

Experimental group

Description:

After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.

Treatment:

Biological: Cetuximab

Biological: Dalotuzumab 10 mg/kg

Drug: Irinotecan

Cetux/Irin - Dmab 15/7.5 mg/kg

Experimental group

Description:

After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long.

Treatment:

Biological: Dalotuzumab 15/7.5 mg/kg

Biological: Cetuximab

Drug: Irinotecan

Dmab 10 mg/kg - Cetux/Irin (DDI)

Experimental group

Description:

Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For Drug-Drug Interaction (DDI). Each cycle was 6 weeks long.

Treatment:

Biological: Cetuximab

Biological: Dalotuzumab 10 mg/kg

Drug: Irinotecan