Trials / Terminated

TerminatedNCT02334319

Ganetespib Window of Opportunity Study in Head and Neck Cancers

A Molecularly Driven Pilot Study of Preoperative Ganetespib in Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Status: Terminated
Phase: Phase 1
Study type: Interventional
Enrollment: 3 (actual)

Sponsor: Emory University · Academic / Other
Sex: All
Age: 19 Years – 79 Years
Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well ganetespib works before surgery in treating patients with stage I-IVA squamous cell carcinoma of the head and neck that can be removed by surgery. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood and tissue in the laboratory from patients receiving ganetespib may help doctors learn more about the effects of ganetespib on cells. It may also help doctors understand how well patients respond to treatment.

Detailed description

Ganetespib is a small molecule inhibitor of HSP90 that is currently being studied in several ongoing clinical trials. Investigators have demonstrated that ganetespib sensitizes colorectal cell lines to the effects of chemo radiotherapy in vitro. Ganetespib may have an anti-tumor effect in head and neck cancer. The investigators propose this pilot study as a first step to examine the activity of ganetespib in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) who have a planned surgical resection. Ganetespib has not been investigated in SCCHN. This protocol is a window of opportunity trial that will be looking at whether there is a rationale for pursuing this agent in future development of clinical trials that would then focus on therapeutic interventions with or without radiotherapy. There are therefore no clinical trials currently opened using ganetespib in SCCHN and listed on ClinicalTrials.gov. It is not clear if patients who receive this drug prior to surgery will benefit from this intervention. In this study, ganetespib will be administered twice weekly (doses approximately 72 hours apart) for 2 weeks, followed by surgery the day after the last dose of the study drug. There will be 3 dose levels, 80, 100 and 150mg/m² as highest dose. These doses were chosen based on the following considerations. In a Phase 1 study (protocol 9090-01) investigating a twice-weekly ganetespib treatment schedule, doses up to 173 mg/m² were well tolerated, with manageable diarrhea and fatigue being the most common adverse events. Extensive correlative studies and pharmacokinetic (PK)/pharmacodynamic (PD) modeling of preclinical data suggest that in humans the effective dose range for ganetespib is 70-150 mg/m². Therefore, 80 mg/m² is within the range of ganetespib effectiveness and 150 mg/m² twice weekly is a well-tolerated dose.

Conditions

Interventions

Type	Name	Description
DRUG	Ganetespib	Given IV
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

Start date: 2014-12-01
Primary completion: 2016-02-01
Completion: 2016-02-01
First posted: 2015-01-08
Last updated: 2016-07-26

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02334319. Inclusion in this directory is not an endorsement.