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You can access this
clinical trial
if you have
Head and Neck Cancer, Locally Advanced or Unresectable
and you are
over 18
years old
1
2
This is a medium phase trial determining
the safety and dosage of the new treatment, as well as its efficacy.
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The purpose

Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle. Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many cancers. Several mechanisms have been described: (i) Amplification or overexpression of cyclin D1, (ii) Amplification of CDK4, (iii) Activating mutation of CDK4, and (iv) Loss of the CDK4 inhibitor, p16 (CDKN2A). Human Papilloma Virus (HPV) plays a major role in squamous cell carcinoma of head and neck (SCCHN) carcinogenesis. It induces many alterations in the CDK4-Cyclin D-Rb and apoptotic pathways such as up-regulation of p16, loss of Rb and p53 functions. A novel therapy for HPV-negative SCCHN is clearly an unmet medical need. Palbococlib (PD 0332991) is an orally active, highly selective inhibitor of the CDK4/6 with ability to block Rb phosphorylation in the low nanomolar range. The most advanced development is in a treatment of metastatic breast cancer. In addition, palbociclib showed a radiosensitization property. Since combination of cetuximab and radiation improved PFS and overall survival (OS) in locally advanced unresectable SCCHN when compared with radiation alone, these provide a strong rationale to evaluate a combination of palbociclib, cetuximab, and radiation for locally advanced unresectable SCCHN. Because many genetic alterations in SCCHN significantly involve in the CDK4-cyclin D-Rb pathway, predictive biomarker(s) of palbociclib in this combination will be explored. Thus, the investogators propose a non-randomized, dose escalation, phase I study designed to determine the maximum tolerated dose (MTD) and toxicity of palbociclib, cetuximab, and IMRT for locally advanced unresectable SCCHN.

Provided treatments

  • Drug: Palbociclib
  • Drug: Palbociclib
  • Drug: Palbociclib
  • Drug: Palbociclib
  • Drug: Cetuximab
  • Radiation: Intensity Modulated Radiation Therapy
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Locations near you

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Tris trial is registered with FDA with number: NCT03024489. The sponsor of the trial is Mahidol University and it is looking for 33 volunteers for the current phase.
Official trial title:
A Phase I/II Dose Escalation Study of the CDK4/6 Inhibitor, Palbociclib in Combination With Cetuximab and Intensity Modulated Radiation Therapy (IMRT) for Locally Advanced Unresectable Squamous Cell Carcinoma of the Head and Neck