Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amifostine · 2 trials · 8 indications
| Arm | Type | Description |
|---|---|---|
| Arm A Amifostine | ACTIVE_COMPARATOR | Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received; * 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). * Subcutaneous daily amifostine at a dose of 500 mg |
| Arm B No-Amifostine | EXPERIMENTAL | Patients with newly diagnosed, locally advanced stage ill or IV SCCHN \- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). |
| Name | Type | Description |
|---|---|---|
| Amifostine | DRUG | Given subcutaneously |
| Carboplatin | DRUG | Given IV |
| Paclitaxel | DRUG | Given IV |
| radiation | RADIATION | Given once daily for 4 weeks and then twice daily for 2 weeks. |
Inclusion Criteria * Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated. * Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be inc...
Amifostine is a small molecule being studied for chemotherapeutic agent toxicity and esophagitis in oncology. It is being investigated to prevent radiochemotherapy-induced esophagitis and pneumonitis in patients with unresectable non-small cell lung cancer, and for chemotherapeutic agent toxicity, mucositis, radiation toxicity, and xerostomia in head and neck cancer.
Amifostine is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology settings.
Amifostine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, with a total enrollment of 130 and 58 participants respectively.
Amifostine has two completed Phase 2 trials: NCT00081315, studying subcutaneous amifostine for radiochemotherapy-induced esophagitis and pneumonitis in unresectable non-small cell lung cancer, and NCT00095927, a randomized trial for head and neck cancer. Both were conducted in the United States.
Amifostine is also known as Ethyol. In clinical trial NCT00081315, the drug is referred to as subcutaneous Amifostine (Ethyol®), confirming that these names refer to the same drug.
Amifostine is a small molecule, but its specific molecular target is not disclosed in the available information. It is being studied for its potential to protect against chemotherapy and radiation therapy side effects in oncology patients.