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Expansion Trial for Axitinib In Head And Neck Cancer
Phase 2 trial testing Axitinib in Squamous Cell Carcinoma of the Head and Neck in 29 participants. Completed in 9 April 2020.
| Lead sponsor | University of Michigan Rogel Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 30 August 2016 |
| Primary completion | 9 April 2020 |
| Estimated completion | 9 April 2020 |
| Sites | 1 location across United States |
University of Michigan Rogel Cancer Center
18 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluable defined as any participant who receives at least one cycle of Axitinib. Number of evaluable patients and percentage of patients alive at 6 months is reported.
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 71 | 53 – 85 |
median will be calculated by Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 9.8 | 5.9 – 12.2 |
Median will be calculated by Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 3.5 | 2.4 – 5.4 |
Tabulation of best response measured by Choi. Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progression (PD) at 16 weeks. CR is defined as no new lesions and the disappearance of all lesions. PR is defined as a decrease in size of ≥ 10% or a decrease in tumor density (HU) ≥ 15% on CT (Computerized Tomography), no new lesions and no obvious progression of non-measurable disease
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 10 | |
| Axitinib | 3 | |
| Axitinib | 11 | |
| Axitinib | 1 |
Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For any treatment-related toxicity that occurred at any grade with a frequency greater than 10% in the overall study population, grade 3 or worse toxicities are shown here.
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Axitinib | 1 |
Time frame: AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Axitinib |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Sepsis | Infections and infestations | — |
| Cardiac arrest | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Infections and infestations - Other | Infections and infestations | — |
| Lung infection | Infections and infestations | — |
| Upper respiratory infection | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Reaction | System | Axitinib |
|---|---|---|
| Fatigue | General disorders | — |
| Hypertension | Vascular disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Weight loss | Investigations | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Oral pain | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Dermatitis radiation | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Depression | Psychiatric disorders | — |
| Insomnia | Psychiatric disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Eye disorders - Other | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dry mouth | Gastrointestinal disorders | — |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Alanine aminotransferase increased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Diarrhea, Sepsis, Cardiac arrest, Abdominal pain, Cholecystitis, Infections and infestations - Other, Lung infection, Upper respiratory infection.
Data from ClinicalTrials.gov NCT02762513 adverse events section.
This study will be a prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma. The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression or intolerable toxicity.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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