Pharmacodynamic Study to Assess the Anti-proliferative Activity of the PARP Inhibitor Olaparib in Patients With HPV Positive and HPV Negative HNSCC

Sponsor
Yale University
Study ID
NCT02686008
Phase
PHASE1
Status
Withdrawn

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Patients will receive olaparib administered at 300 mg bid x 14 days orally

Study Details

This is an open label pilot study evaluating the pharmacodynamics and safety of single agent olaparib administered at 300mg bid (twice a day) for 14 days orally in patients with human papillomavirus (HPV) -positive and human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC)

Key Dates

Start date
Jan 31, 2018
Status verified
Jan 2020
Primary completion
Jan 31, 2019
Completion
Jul 31, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HPV negative tumors
    10 patients with HPV negative tumors: Non-oropharyngeal tumors or p16 negative and HPV negative oropharyngeal tumors
  • Experimental: HPV positive tumors
    10 patients with HPV positive tumors: p16 positive and HPV positive tumors

Primary Outcome Measure

Change in Level of IHC-Ki-67 expression [ Time Frame: Baseline and 14 days ]

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