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MinorTrial status: Recruiting to Active, Not RecruitingSite details revisedv13Show 1 more changeShow less
Site details revised
NotablePrimary endpoints revised (2)Eligibility criteria shortened, about 24 words · Secondary endpoints revised (12) · Study description shortened, about 53 wordsv12Show 3 more changesShow less
NotablePrimary completion date: Dec 2022 to Dec 2024Completion date: Dec 2024 to Dec 2026v7Show 1 more changeShow less
Completion date: Dec 2024 to Dec 2026
NotablePrimary completion date: Dec 2021 to Dec 2022v6
NotableLead sponsor: Chi Lin, MD to Chi Lin, MD, PhDv5
NotablePhase: Phase 1 to Phase 1/2Primary completion date: Dec 2019 to Dec 2021 · Primary endpoints: 1 to 2 · Completion date: Dec 2020 to Dec 2024 · 2 morev4Show 5 more changesShow less
Primary completion date: Dec 2019 to Dec 2021
Primary endpoints: 1 to 2
Completion date: Dec 2020 to Dec 2024
Secondary endpoints: details revised at 12 of 12 entries
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Over 80% of anal cancers are squamous cell carcinoma (SCC). Current standard treatment for locally advanced squamous cell carcinoma of the anal canal is a combination of radiation therapy (RT) and concurrent chemotherapy. This allows for organ preservation in approximately 75% of patients. The use of concurrent radiation and chemotherapy with infusional 5-fluorouracil (5-FU) and mitomycin results in locoregional relapse rates of 20-32 and 5-year overall survival rates of 58-78%. However, while mitomycin significantly increases the rate of grade 4 toxicities, it improves local outcomes and has been considered a necessary agent in the care of anal cancer. Oxidative stress induced by radiotherapy and chemotherapy tends to protect tumor cells and promote normal tissue damage. A recently developed compound, BMX-001 (MnTnBuOE-2- PyP5+), is among the most highly potent metalloporphyrin compounds which reduce oxidative stress, thereby protecting normal tissues and augmenting tumor killing.
In this Phase 1/2 study, the investigators will conduct a safety and efficacy study of the combination of BMX-001 with standard radiation therapy and concurrent (5FU)/mitomycin in newly diagnosed Anal Squamous Cell Carcinoma (ASCC) patients. The primary Phase 1 objective is to determine the maximum tolerated dose (MTD) of BMX-001 in ASCC patients receiving RT and concurrent 5FU/mitomycin chemotherapy. Three participants will be treated at Dose Level 1 and three at Dose Level 2, then three at Dose Level 3. Dose Limiting Toxicities (DLT) experienced by any participant will be used to determine the MTD. The Phase II objective is to examine the impact of BMX-001 on the overall acute ≥ grade 3 toxicity rate of the normal tissue including rectum, bladder, and skin in combination with RT and concurrent 5FU/mitomycin in treatment of newly diagnosed ASCC patients. These will be determined by participant reports, biological materials (blood, tissue, urine) sampling and imaging. Participant health-related quality of life will be assessed by two questionnaires.