Spots Global Cancer Trial Database for A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC
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Trial Identification
Brief Title: A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
Study ID: NCT04844983
Conditions
Study Description
Brief Summary: The purpose of this trial is to evaluate safety, tolerability and efficacy of various doses of STP705 administered as intralesional injection in subjects with cutaneous squamous cell carcinoma (in situ) skin cancer (isSCC).
Detailed Description: This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with isSCC. A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once weekly for 6 weeks. After 6 weeks, the lesion will be excised. In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705 doses or placebo. An interim analysis will be done after all subjects have completed end of treatment (EOT) visits to determine 2 selected dose levels of STP705 to be used in part of the study. In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses (from part 1) or placebo. In both parts at the End of Treatment (EOT), the lesion will be excised.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigate MD, Scottsdale, Arizona, United States
Center for Clinical and Cosmetic Research, Aventura, Florida, United States
Research Institute of the Southeast LLC, West Palm Beach, Florida, United States
Dermatology, Laser and Vein Specialists of the Carolinas, Charlotte, North Carolina, United States
Dermatology Associates of Knoxville, Knoxville, Tennessee, United States
Tennessee Clinical Research, Nashville, Tennessee, United States
Austin Institute for Clinical Research, Pflugerville, Texas, United States
Contact Details
Name: Mark Nestor, MD
Affiliation: Center for Clinical and Cosmetic Research
Role: PRINCIPAL_INVESTIGATOR
Name: David Goldberg
Affiliation: Schweiger Dermatology Group
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Gold, MD
Affiliation: Tennessee Clinical Research
Role: PRINCIPAL_INVESTIGATOR
Name: Edward Lain, MD
Affiliation: Austin Institute for Clinical Research
Role: PRINCIPAL_INVESTIGATOR
Name: Kenneth Beer, MD
Affiliation: Research Institute of the Southeast LLC
Role: PRINCIPAL_INVESTIGATOR
Name: Brenda LaTowsky, MD
Affiliation: Investigate MD
Role: PRINCIPAL_INVESTIGATOR
Name: Edward Primka, MD
Affiliation: Dermatology Associates of Knoxville
Role: PRINCIPAL_INVESTIGATOR
Name: Girish Munavalli, MD
Affiliation: Dermatology, Laser and Vein Specialists of the Carolinas
Role: PRINCIPAL_INVESTIGATOR
Name: Brian Jiang, MD
Affiliation: UCSD Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Megan Couvillion, MD
Affiliation: SBA Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Ling, MD
Affiliation: Medaphase Inc
Role: PRINCIPAL_INVESTIGATOR
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