Clinical trial · Interventional
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)
NCT00513435CI-TRIAL-00014383completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (39)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma | — | UNRESOLVED | — |
| Recurrent Metastatic Squamous Neck Cancer With Occult Primary | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Nasopharynx | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| saracatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy)
- description
- Patients 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.
- interventionNames
- Drug: saracatinib
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- From the start of treatment for up to 12 weeks
- description
- Response was determined as inicated in the protocol.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.