Study of Pomalidomide in Anal Cancer Precursors (NCT03113942) | Clinical Trial Compass
UnknownPhase 2
Study of Pomalidomide in Anal Cancer Precursors
Australia26 participantsStarted 2017-06-14
Plain-language summary
This is a single centre open label phase II trial to determine the antitumor efficacy of the oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated high grade squamous intra-epithelial lesions (HSIL) in patients with and without human immunodeficiency virus (HIV) infection.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Persistent high grade squamous intra-epithelial lesion (HSIL) which must meet all of the following criteria:
ā. No history of thromboembolic disease
ā. No evidence of anal cancer or Superficially Invasive Squamous Cell Carcinoma of the Anus (SISCCA)
ā. Willingness to use appropriate contraception (including refraining from sperm donation)
ā. Age 18 years or older
ā. Provision of written informed consent
ā. Adherence to a stable suppressive antiretroviral therapy (ART) regimen, unchanged for at least two months
ā. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> three times upper limit of normal
ā. Calculated or measured creatinine clearance (CLCr) ā¤ 50 mL/min (calculated by Cockcroft-Gault formula)
ā. Patients with significant cardiac dysfunction including congestive heart failure, NY Heart Association Class II; Myocardial infarction within 12 months of starting study; unstable of poorly controlled angina
What they're measuring
1
Histological High Grade Squamous Intraepithelial Lesions (HSIL) clearance at 6 months of therapy
ā. Any condition not already outlined above which, in the opinion of the clinical investigator, would place the subject at risk if they participated or would jeopardise adherence or follow up