Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Bestim.

This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1.

The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx.

The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits.

It had four arms (groups): Placebo (placebo comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 160 planned participants were the target.

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: Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB). Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Have adequate hematopoietic, hepatic, and renal function at the screening visit:. Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3. Platelet count ≥ 100 × 109/L.

The full record lists 17 inclusion and 17 exclusion criteria; among the exclusions: tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor; metastatic disease (m1) stage iv c; prior radiation to the head and neck.

How the Study Was Run

The set-up was randomized, single-group and quadruple-blind.

Because people in this Bestim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Bestim, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-12 with completion listed for 2014-06.

It ran at 49 sites in United States (49).

Its stated primary purpose is prevention.

What Was Measured

It also tracked 1 secondary outcome, for example Safety.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bestim in 160 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Bestim compound page, all human trials.