AzTrials
AzTrials

Stage I Hypopharyngeal Squamous Cell CarcinomaPhase 1NCT02334319

Ganetespib Window of Opportunity Study in Head and Neck Cancers

A Phase 1 study testing Ganetespib, Therapeutic Conventional Surgery and Laboratory Biomarker Analysis in people with Stage I Hypopharyngeal Squamous Cell Carcinoma and Stage I Laryngeal Squamous Cell Carcinoma, run by Emory University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 79 years
What is being tested?
Ganetespib, Therapeutic Conventional Surgery and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
Dec 2014to Feb 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
  • Disease may be stage I, II, III or IVa (as long as it is deemed resectable by the surgical team)
  • Tumor must be surgically resectable and curable with conventional surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients must give documented informed consent to participate in this study
  • Absolute-neutrophil count (ANC) ≥ 1500/mm³
Show all 12Show fewer
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ within upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Lipase levels < 1.5 x ULN
  • Amylase levels < 1.5 x ULN

Who cannot join

  • Prior therapy with a known heat shock protein 90 (HSP90) inhibitor
  • Poor venous access for study drug administration; in this case, patients would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time unless silicone based catheters are used; anything other than catheters made from silicone are not allowed with ganetespib therapy
  • History of severe allergic or hypersensitivity reactions to excipients (e.g., polyethylene glycol [PEG] 300 and polysorbate 80)
  • Treatment with chronic immunosuppressant (e.g., cyclosporine following transplantation)
  • Uncontrolled undercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
Show all 25Show fewer
  • Documented evidence of distant metastases or brain metastases
  • Active malignancy besides head and neck squamous cell cancer (HNSCC) or primary skin basal cell carcinoma; (patients with a concomitant malignancy that has not progressed within 12 months of study entry are eligible)
  • History of documented congestive heart failure (CHF), New York Heart Association class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics; NOTE: use of these medications for the treatment of hypertension is allowed
  • Peripheral neuropathy that is grade 2 or higher
  • Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception
  • Patients residing in prison
  • CARDIAC EXCLUSION CRITERIA:
  • Known serious cardiac illness or medical conditions, including but not limited to:
  • Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
  • Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a class Ia antiarrhythmic drug (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide); use of other antiarrhythmic drugs is permitted
  • Use of medications that have been linked to the occurrence of Torsades de pointes
  • Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker
  • Complete left bundle branch block (LBBB)
  • History of long QT syndrome or a family member with this condition
  • Corrected QT (QTc) > 470 ms (average of triplicate electrocardiogram [ECG] recordings); a consistent method of QTc calculation must be used for each patient's QTc measurements; QTcF (Fridericia's formula) is preferred
  • Serum potassium, magnesium, or calcium levels in the following ranges:
  • Potassium < 3.4 or > 5.1 mmol/L
  • Magnesium < 1.4 or > 2.4 mg/dL
  • Calcium < 8.9 or > 10.5 mg/dL

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Ganetespib, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GanetespibDrug

    Also called Hsp90 Inhibitor STA-9090, STA-9090

    Given IV

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02334319
Study groupRoleWhat they receive
Treatment (ganetespib, surgery)ExperimentalPatients receive ganetespib IV over 1 hour twice weekly for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery the day after the last dose of ganetespib.
Receives: Drug: Ganetespib; Procedure: Therapeutic Conventional Surgery; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in expression of biomarkers in tissue samples, assessed by immunohistochemistry (IHC)

    The biomarker expression of pre-, post-treatment, and their change will be described by summary statistics along with 95% confidence interval (CI) for the estimated mean. A paired sample Wilcoxon signed rank test will be considered to test whether the mean of post-treatment expression is different from the pre-treatment expression. This analysis will be done separately by each of the three dose levels, and by pooling all dose levels together. Kruskal-Wallis test will also be carried out.

    Measured: Baseline to up to 24 months

  2. Change in biomarker expression in blood samples

    The biomarker expression of pre-, post-treatment, as well as their change will be described by summary statistics along with 95% CI for the estimated mean. A paired sample Wilcoxon signed rank test will be considered to test whether the mean of post-treatment expression is different from that of the pre-treatment expression. This analysis will be done separately by each of the three dose levels, as well as by pooling all dose levels together. Kruskal-Wallis test will also be carried out.

    Measured: Baseline to up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02334319
Sponsor's protocol ID
IRB00070264
Other IDs
WINSHIP2572-13, NCI-2014-02605
Status last verified
Jul 2016
First submitted
6 Jan 2015
Last updated
26 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ganetespib, Therapeutic Conventional Surgery and Laboratory Biomarker Analysis in people with Stage I Hypopharyngeal Squamous Cell Carcinoma and Stage I Laryngeal Squamous Cell Carcinoma, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in expression of biomarkers in tissue samples, assessed by immunohistochemistry (IHC) (time frame: Baseline to up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02334319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in