Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03030885 | Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC) | PHASE1 | COMPLETED | 10 | — | — | Jan 19, 2017 | Apr 2, 2019 | Apr 5, 2019 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 131I-MIP-1095 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| 131I-MIP-1095 | DRUG | 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 |
Inclusion Criteria: * Males, age ≥18 years. * Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate * Subjects must be castration resistant with evidence of progressive prostate cancer despite castrate levels of testosterone (≤ 50 ng/dL) according to the PCWG3 ...