Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT02381535
Brief Summary:
This phase I trial studies the side effects and best dose of onalespib when given together with intensity-modulated radiation therapy (IMRT) and cisplatin in treating patients with squamous cell carcinoma of the head and neck that has spread from where it started to nearby tissue or lymph nodes. Onalespib works by blocking a protein called HSP90. HSP90 helps protect cells from stress and supports many other proteins that cause cell growth. When HSP90 is blocked, tumor cell growth may be slowed or stopped and may die more easily when treated with chemotherapy and radiation. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. IMRT is a specialized radiation therapy that delivers beams of radiation of different intensities aimed at the tumor from many angles and may kill more tumor cells and cause less damage to normal tissue. Giving onalespib with cisplatin and IMRT may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the safety and recommended phase II dose (RP2D) of onalespib (AT13387) in combination with concurrent cisplatin and radiotherapy in patients with locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). (Dose Escalation Phase) II. To preliminarily evaluate the safety and preliminary efficacy of AT13387 in combination with concurrent cisplatin and radiotherapy in patients with LA-SCCHN. (Dose Expansion Phase)
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of AT13387 in combination with cisplatin and radiotherapy.
II. To evaluate the pharmacokinetics of cisplatin in combination with AT13387 and radiotherapy.
III. To assess for pharmacodynamics biomarkers for proof-of-mechanism. IIV. To assess for potential predictive biomarkers of efficacy. V. To document the toxicities associated with the administration of AT13387 in combination with cisplatin and radiotherapy in patients with LA-SCCHN.
VI. To explore and characterize predictive biomarkers for individual cancer patients utilizing genomic sequencing technologies.
VII. To provide preliminary disease-free survival, locoregional control, distant metastases-free survival, and overall survival.
OUTLINE: This is a dose-escalation study of onalespib.
Patients receive onalespib intravenously (IV) over 1 hour on days -7, 3, 10, 24, 31, and 38 and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43. Patients also undergo IMRT once daily (QD), 5 days a week over 7 weeks for a total of 35 fractions. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 8 weeks, every 3 months for 1 year, and then every 6 months for 1 year. Beyond the first 2 years, patients may be followed up every 6 months for up to 3 years per institutional standards.
Study:
NCT02381535
Study Brief:
Protocol Section:
NCT02381535