Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Phase I Study of LEE011plus Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
In this trial, the investigators would like to investigate the activity of LEE011 associated with cetuximab (standard of care for the SCCHN patients at this stade of the disease).
In the mammalian cell cycle, entry into S phase is achieved by cyclin-dependent kinases 4 and 6 (CDK4/6), which activate a family of E2F transcription factors by phosphorylating and deactivating the retinoblastoma protein (pRb). LEE011 is an orally, highly selective small molecule inhibitor of CDK4/6 that potently induces G1 arrest with sub-micromolar IC50's in a variety of pRb-positive cancer cells. A recent study showed that an inhibitor of the CDK4-CCND1 complex showed promising results in SCCHN pre-clinical models. There is a strong rationale to investigate CDK inhibitors in this disease. In phase Ib/II study as a single agent, the major toxicities observed were Grade 3 and 4 fatigue (53.8%), nausea (50.8%), neutropenia (47.7%), anemia (37.1%), leukopenia (46.2%), thrombocytopenia (34.1%), diarrhea (32.6%), vomiting (34.8%), lymphocytes count decreased (30.3%), anorexia (21.2%), hyperglycemia (21.2%), constipation (19.7%), hypoalbuminemia (18.9%), dyspnea (18.2%) and cough (16.7%). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Recruiting |
NCT06236464 -
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
|
||
| Terminated |
NCT04659369 -
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT02572778 -
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer
|
||
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Terminated |
NCT01488318 -
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT00999700 -
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
|
Phase 3 | |
| Completed |
NCT02565758 -
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02543476 -
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
|
N/A | |
| Recruiting |
NCT03938012 -
Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma
|
||
| Terminated |
NCT02124850 -
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
|
Phase 1 | |
| Active, not recruiting |
NCT03313804 -
Priming Immunotherapy in Advanced Disease With Radiation
|
Phase 2 | |
| Recruiting |
NCT05208762 -
A Study of SGN-PDL1V in Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04453046 -
Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
|
N/A | |
| Completed |
NCT01758731 -
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
|
Phase 1 | |
| Completed |
NCT02473731 -
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients
|
Phase 1 | |
| Completed |
NCT02022098 -
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
|
N/A | |
| Completed |
NCT01458392 -
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
| Completed |
NCT02882308 -
Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.
|
Phase 2 |