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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01384799 | Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer | PHASE1 | COMPLETED | 12 | — | — | Nov 1, 2011 | Oct 1, 2013 | Feb 22, 2018 | 7 | United States |
| NCT01171924 | A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors | PHASE1 | COMPLETED | 47 | — | — | Jul 1, 2010 | Oct 1, 2011 | Mar 1, 2016 | 7 | United States |
Safety and tolerability will be assessed by evaluating the number of patients with adverse events
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
| Arm | Type | Description |
|---|---|---|
| Arm A: 5 days/week schedule | EXPERIMENTAL | - |
| Arm B: 3 days/week schedule | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CUDC-101 | DRUG | CUDC-101 will be administered as a 1 hour intravenous infusion three times per week for a one week run-in (week -1) and then as part of the combination treatment on weeks 1-7. If the 225 mg/m2 dose is tolerated in the first cohort, the dose will be increased to 275 mg/m2. If the 225 mg/m2 dose is not tolerated, the dose will be decreased to 175 mg/m2. If 175 mg/m2 is not tolerated the dose will be further decreased to 150 mg/m2. |
| Cisplatin | DRUG | Cisplatin will be administered intravenously at a dose of 100 mg/m2 on days 2, 23 and 44 of the seven week combination treatment course. |
| Radiation Therapy | RADIATION | The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions per week. The gross disease sites will receive 70 Gy in 35 fractions over seven weeks and the subclinical disease sites will receive 56 Gy in 35 fractions, again over seven weeks. |
Inclusion Criteria: * Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell carcinoma of the head and neck at the following sites: oral cavity, oropharynx, hypopharynx and larynx with either: * Stage IV p16 positive tumors and \>10 pack-years smoking history. * St...