Clinical trial · Interventional
Efficacy of SU 011248 in Head And Neck Carcinoma
A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
NCT00408252CI-TRIAL-00040715terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Too frequent grade 3-4 toxicities
Summary
Brief summary (as posted)
Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Palliative Treatment | — | UNRESOLVED | — |
| Recurrent Disease | — | UNRESOLVED | — |
| Squamous Cell Head and Neck Carcinoma | Head and Neck Squamous Cell Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsies | Other | — | UNRESOLVED |
| SU011248 | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- patients will receive SU011248 in monotherapy
- interventionNames
- Other: biopsies
- Drug: SU011248
Primary outcomes (1)
- measure
- Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
- timeFrame
- every 6 weeks
Secondary outcomes (3)
- measure
- Determine the safety profile of SU011248 alone in patients with head and neck cancer.
- timeFrame
- untill disaese progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation * Recurrence must be confirmed by anatomopathology (cytology or biopsy) * At least one measurable lesion by MRI or CT-scan * Failed or relapsing after first line chemotherapy including a platinum\* or a taxane-based chemotherapy regimen * Patients ineligible for chemotherapy could be included in first line * ECOG performance status 0 -2, in stable medical condition * Patients must be able to swallow tablets * Patients must have an expected survival of at least 3 months * Paraffin-embedded tumor tissue available for immunohistochemistry * Patients must be over 18 years old and must be able to give written informed consent * Women of child-bearing age must have a negative pregnancy test * Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection * Patients must have normal organ function * For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later) * Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis * Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248 * Signed informed consent prior to beginning protocol specific procedure Exclusion Criteria: * Non-squamous head and neck cancer * Nasopharynx cancer * Brain metastases * More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent) * Surgery or irradiation or investigational drugs within 4 weeks before study inclusion * Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …) * Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%) * Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * Other concomitant anticancer therapies * Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria. * Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
References
Publications (0)
Data not yet available
No reference posted for this study.