A Phase I Study of MLN6907 in Patients With Metastatic Colorectal

Phase 1

Completed

• Conditions: Imaging of Solid Gastrointestinal Tumors
• Interventions: Drug: [68Ga]MLN6907

• Registration Number: NCT02056015
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Study Start: 2015-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[68Ga]MLN6907	[68Ga]MLN6907	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements	Duration of study up to 26 months
Human organ and whole body absorbed dose values from organ kinetic quantification of [68Ga]MLN6907 uptake and clearance	Day 1

Secondary Outcome Measures

Name	Time	Method
Correlate tumor uptake of [68Ga]MLN6907 measured by PET and the level of guanylyl cyclase C (GCC) expression in tumor lesions from surgical specimens , for tumors in individual patients and for aggregated liver tumors across patients	Duration of study up to 26 months
Expert visual rating of [68Ga]MLN6907 liver tumor uptake and quantitative measurement of tumor-to-background (normal liver, muscle, etc.) ratio for each liver tumor	Duration of study up to 26 months
Time-activity curves for each liver tumor region of interest (ROI) and kinetic curves of the ratio of each liver tumor to background (including for normal liver, muscle, and blood); determination of the time for the maximum ratio for each tumor lesion	Duration of study up to 26 months
Plasma [68Ga]MLN6907 and MLN6907 drug substance precursor PK parameters and quantification of GCC levels in liver metastases	Day 1	PK parameters include single-dose maximum (peak) concentration (Cmax), single-dose time to reach maximum (peak) concentration (Tmax), terminal disposition half-life (t1/2), and area under the plasma concentration versus time curve (AUC).