NCT02056015

A Phase I Study of MLN6907 in Patients With Metastatic Colorectal

A Phase 1, First-in-Human, Single-Dose, Open-Label, Positron Emission Tomography (PET) Imaging Study of [68Ga]MLN6907 in Patients With Metastatic Colorectal Carcinoma.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of \[68Ga\]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their treatment plan will be eligible for enrollment.

Conditions

• Imaging of Solid Gastrointestinal Tumors

Interventions

Type	Name	Description
DRUG	[68Ga]MLN6907	IV Administration of \[68Ga\]MLN6907 on Day 1

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-02-05
• Last updated: 2017-01-05

Locations

2 sites across 2 countries: United States, Mexico