Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CUDC-101 · 3 trials · 6 indications
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.
The maximum tolerated dose is the highest dose level at which \<33% of at least 6 or more subjects experiences a dose limiting toxicity.
The number of patients with adverse events will be assessed to determine the safety and tolerability of CUDC-101.
| 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...
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CUDC-101 is an investigational small molecule being studied for the treatment of head and neck cancer and other advanced solid tumors, including gastric, breast, liver, and non-small cell lung cancer. It is developed by Curis, Inc. and is currently in Phase 1 clinical development.
CUDC-101 is developed by Curis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CRIS. The drug is an investigational small molecule in Phase 1 clinical development for oncology indications.
CUDC-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, but the drug remains in early-stage development.
CUDC-101 has been studied in three completed Phase 1 clinical trials: NCT00728793 in advanced solid tumors, NCT01171924 in head and neck, gastric, breast, liver, and non-small cell lung cancer, and NCT01384799 in head and neck cancer with cisplatin and radiation.
No alternative names for CUDC-101 have been identified in the available information. It is referred to solely as CUDC-101 in clinical trial records and by its developer, Curis, Inc.