Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
4 other identifiers
interventional
9
1 country
1
Brief Summary
This phase II trial is studying the how well saracatinib works in treating patients with metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 6, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
October 18, 2013
CompletedApril 30, 2014
August 1, 2013
3.7 years
August 6, 2007
August 13, 2013
April 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Response was determined as inicated in the protocol.
From the start of treatment for up to 12 weeks
Secondary Outcomes (1)
Overall Survival
Up to 12 weeks
Study Arms (1)
Treatment (enzyme inhibitor therapy)
EXPERIMENTALPatients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
- Persistent, recurrent, or metastatic disease that is not amenable to curative-intent therapy with surgery or radiation
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan
- Karnofsky performance status ≥ 60%
- White blood cell (WBC) ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin \> 9 g/dL
- Total bilirubin within upper institutional limits of normal (ULN)
- Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatinine within ULN OR creatinine clearance ≥ 60 mL/min
- Patients must agree to use adequate birth control for the duration of study participation and for at least 8 weeks after discontinuation of study drug
- May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic disease
You may not qualify if:
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
- Urine protein: creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg
- QTc prolongation ≥ 480 msecs
- Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- History of myocardial infarction within the past year
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
- Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or pneumonitis/pulmonary infiltrates ≥ grade 2
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Use of specifically prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances
- Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
- Patients receiving any other investigational agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthew Fury, MD
- Organization
- Memorial Sloan-Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Fury
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2007
First Posted
August 8, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 30, 2014
Results First Posted
October 18, 2013
Record last verified: 2013-08