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MLN6907

Phase 1

Imaging of Solid Gastrointestinal Tumors | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jan 5, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

MLN6907 · 1 trial · 1 indication

Phase 1 1
NCT02056015A Phase I Study of MLN6907 in Patients With Metastatic ColorectalImaging of Solid Gastrointestinal Tumors
COMPLETED20 Analytics
PHASE1COMPLETED
A Phase I Study of MLN6907 in Patients With Metastatic Colorectal
Imaging of Solid Gastrointestinal Tumors
NCT0205601520
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
[68Ga]MLN6907EXPERIMENTAL -

Interventions

NameTypeDescription
[68Ga]MLN6907DRUGIV Administration of \[68Ga\]MLN6907 on Day 1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Male or female patients 18 years or older. * Must be diagnosed with colorectal cancer (CRC) with liver metastasis and eligible and scheduled for resection of liver metastases as part of...

Countries:United StatesMexico
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