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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00455052 | A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 30 | — | — | Mar 1, 2011 | Dec 1, 2011 | Jan 31, 2018 | 12 | United States |
| Arm | Type | Description |
|---|---|---|
| XMT-1001 | EXPERIMENTAL | XMT-1001 is administered I.V. every 21 days. Groups of 3 patients are given one dose and the dose increases for each group. The first dose level is 17 mg/m\^2, the next dose level is 30 mg/m\^2, followed by dose levels: 50 mg/m\^2, 80 mg/m\^2, 120 mg/m\^2, 150 mg/m\^2, and 190 mg/m\^2 until disease progressions or unacceptable side effects are experienced. |
| Name | Type | Description |
|---|---|---|
| XMT-1001 | DRUG | XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD. |
Inclusion Criteria: 1. At least 18 years old 2. Have histological or cytological documentation of one of the following: A. NSCLC with Stage IV disease according to the American Joint Cancer Commission TNM Staging (7th Edition) * Have received at least one prior chemotherapy regimen but no mo...