Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OSI-774 · 1 trial · 1 indication
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded, NE = not evaluable
| Arm | Type | Description |
|---|---|---|
| Cisplatin + Docetaxel + OSI-774 | EXPERIMENTAL | Cisplatin 75 mg/m\^2 IV every 21 days. Docetaxel 60 mg/m\^2 IV repeated every 21 days. OSI-774 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached. |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | 60 mg/m\^2 IV repeated every 21 days. |
| OSI-774 | DRUG | 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached. |
| Cisplatin | DRUG | 75 mg/m\^2 IV every 21 days. |
Inclusion Criteria: 1. Have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx. 2. Have measurable disease, defined as at least one lesion that can ...
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OSI-774 is an investigational small molecule being studied for the treatment of Head and Neck Cancer, specifically head and neck squamous cell carcinoma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
OSI-774 is a small molecule that targets the epidermal growth factor receptor (EGFR) pathway. By inhibiting this receptor, it aims to interfere with cancer cell growth and survival in head and neck squamous cell carcinoma.
OSI-774 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker symbol RHHBY.
OSI-774 is currently in Phase 2 clinical development for Head and Neck Cancer. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory bodies for commercial use.
OSI-774 has one completed Phase 2 clinical trial, identified as NCT00076310, titled 'OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer'. This trial enrolled 50 participants in the United States and was an uncontrolled, non-randomized study.
OSI-774 is also known as erlotinib, a small molecule EGFR inhibitor. In the context of this development program, OSI-774 refers to the same compound being evaluated for head and neck cancer.