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)
Sponsor study identifier
interventional
10
1 country
1
Study Start
January 19, 2017
Actual (reported)Primary Completion
April 2, 2019
Actual (reported)Study Completion
April 2, 2019
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2017
Actual (reported)January 22, 2017
Actual (reported)January 25, 2017
Actual (reported)April 2, 2019
Actual (reported)April 2, 2019
Actual (reported)Maximum Tolerated Dose (MTD)
This is a phase 1 dose escalation study of 131I-MIP-1095 in men with metastatic castration-resistant prostate cancer. There are a maximum of five doses under consideration. Dose escalation cohorts will be studied if acceptable toxicity is observed. A dose limiting toxicity is defined as the occurrence of any of the following drug-related toxicities during the first cycle.
2 years
FirstTherapeutic 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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Laccetti AL, Bodei L, O'Donoghue JA, Weber WA, Morris MJ. 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. Clin Nucl Med. 2023 Nov 1;48(11):937-944. doi: 10.1097/RLU.0000000000004818.
Michael Morris, MD
Memorial Sloan Kettering Cancer Center
10 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2017
First Posted
January 25, 2017
Contact the study team to confirm eligibility.
Study Start
January 19, 2017
Actual (reported)Primary Completion
April 2, 2019
Actual (reported)Study Completion
April 2, 2019
Actual (reported)Last Updated
April 5, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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