Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study

What Was Tested

This registered early phase 1 trial tested Amylin (Islet Amyloid Polypeptide).

This study will treat resectable cutaneous squamous cell carcinoma patients with pramlintide for two weeks prior to surgical resection of their tumor.

Pre-treatment and surgical resection specimens will then be analyzed for biological alterations.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Tumor site must be amenable for surgical resection and accessible for pre-treatment biopsy. Tumor site must be measurable by caliper measurements or by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 imaging - lesions must be ≥1 cm. Eastern Cooperative Oncology Group (ECOG) ≤2 and be medically able to undergo surgical resection. Ability to understand and willingness to sign a written informed consent document. Patients must be willing to comply with the protocol for the duration of the treatment including daily sub-cutaneous (SQ) injections, biopsies, scheduled visits and examinations, radiologic studies, and surgical resection.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: patients with known gastroparesis; patients with known allergic reactions to pramlintide or its ingredients; pregnant women and/or nursing patients will be excluded from this study because of unknown risks to fetus or nursing infants.

How the Study Was Run

It was run as a non-randomized, sequential and open-label study.

Nothing was hidden in this open-label Amylin (Islet Amyloid Polypeptide) study: the participants and staff both knew the treatment.

It started in 2020-01-30 with completion listed for 2023-06-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Participant Compliance (time frame: at 14 days from on study date).

It also tracked 1 secondary outcome, for example Number of Adverse Events.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Amylin (Islet Amyloid Polypeptide) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.