Clinical trial · Interventional
Pazopanib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase II Study of Pazopanib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Refractory to Platinum-Based Chemotherapy
NCT01377298CI-TRIAL-00005041unknownPhase 2ClinicalTrials.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)
Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in cisplatin-refractory recurrent or metastatic HNSCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib
- description
- Single arm study, pazopanib
- interventionNames
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 1 year
- description
- Evaluable for response: From the RECIST 1.1 paper,all patients included in the study must be accounted for in the results, even if there are major protocol treatment deviations or if they are not evaluable.
Secondary outcomes (4)
- measure
- disease control rate (CR+PR+SD),
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
1. Histologically confirmed HNSCC.
2. Recurrent or metastatic setting, refractory to previous cisplatin or carboplatin-based chemotherapy.
3. At least one measurable lesion (according to RECIST v 1.1 criteria).
4. Eastern Cooperative Oncology Group performance status 0 to 2.
5. Age\>18y/o,\<=70y/o.
6. Adequate bone marrow, hepatic, and renal functions as evidenced by the following:
* Absolute neutrophil count\>=1,500 cells/L, platelet count\>=100,000 cells/L, and hemoglobin\>=9 g/dL.
* Total bilirubin\<=1.5 X ULN, AST/ALT\<=3.0 X ULN
* Creatinine\<=1.5 mg/dL.
7. Informed consent, obtained in writing.
Exclusion Criteria:
1. Second malignancy.
2. Locoregional recurrence amenable to definite surgery or radiation again.
3. Brain/meningeal metastasis with IICP or bone metastasis with spinal cord compression.
4. Pregnancy or nursing women.
5. Having received more than two prior lines of intravenous chemotherapy in the palliative setting.
6. Having received antiangiogenesis agent in the palliative setting.
7. Having received chemotherapy or radiation therapy or surgery within 3 weeks.
8. Major systemic diseases those are inappropriate for systemic chemotherapy according to clinician's professional judgment.
9. Mental status not fit for clinical trials.
10. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
* Active peptic ulcer disease
* Known intraluminal metastatic lesion/s with risk of bleeding
* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
11. Corrected QT interval (QTc)\>480 msecs using Bazett's formula.
12. Poorly controlled hypertension defined as SBP\>=140 mmHg or DBP\>=90mmHg
13. Concomitant diseases that might be aggravated by investigational drugs:
* Active or non-controlled infection.
* Severe upper gastrointestinal bleeding.
* History of any one or more of the following cardiovascular conditions within the past 12 months:
* Cardiac angioplasty or stenting,
* Myocardial infarction,
* Unstable angina,
* Symptomatic peripheral vascular disease,
* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
14. Hemoptysis within 6 weeks of first dose of Pazopanib, prior major surgery within 4 weeks of first dose of Pazopanib, or presence of any non-healing wound/fracture.References
Publications (0)
Data not yet available
No reference posted for this study.