NCT03030885

Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 1, Open-Label, Dose Ascending Study to Evaluate the Safety and Tolerability of the Therapeutic Radiopharmaceutical 131I-MIP-1095 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study to determine the safety of an experimental medicine called 131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by the U.S. Food \& Drug Administration (FDA).

Conditions

• Prostate Cancer
• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	131I-MIP-1095	First Therapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose. 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53

Timeline

• Start date: 2017-01-19
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2017-01-25
• Last updated: 2019-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study