MNPR-301-001 (Clinicaltrials.gov Study Identifier NCT04648020)
Validive for the Prevention of Chemoradiation-induced Severe Oral Mucositis (SOM) in Oropharyngeal Cancer (OPC) (VOICE Trial)
Indication: Chemoradiation-induced Severe Oral Mucositis (SOM)
Investigational Therapeutic: Clonidine HCl Mucoadhesive Buccal Tablet (MBT)
Study Type: Phase 2b/3
Goal: The objectives of this program are: to evaluate the effectiveness of clonidine HCl MBT in preventing the occurrence of chemoradiation-induced SOM in patients with OPC; to evaluate the safety of clonidine HCl MBT in patients with OPC treated with chemoradiation.
Status: This study is currently recruiting participants
Validive VOICE Trial
A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Mucoadhesive Buccal Tablet to Placebo to Prevent Chemoradiotherapy-induced Severe Oral Mucositis in Patients with Oropharyngeal Cancer
The VOICE trial is a sequential design Phase 2b/3 multicenter, randomized (1:1), double-blind, placebo-controlled, parallel group study to compare the efficacy and safety of clonidine HCl MBT to placebo MBT in the prevention of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) undergoing chemoradiotherapy (CRT). Best supportive care (BSC) will be allowed as per individual institutional practice with some exceptions as described in the inclusion and exclusion criteria. Eligible patients will be randomized to receive either clonidine MBT or placebo. Patients will be centrally randomized in a 1:1 ratio. The randomization will be stratified by p16 status (positive or negative). Randomized patients will be required to self-apply the study drug to the gum once a day in addition to BSC. The first application of MBT study drug will be performed on Day 1 of the CRT regimen. Each site will require the patient to follow the same local practice for BSC per Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) guidelines with some exceptions as described in the inclusion and exclusion criteria. Daily, self-administered MBT study drug will be continued once daily for the entire duration of CRT treatment; defined as from Day 1 of CRT until the last day of CRT (anticipated to be approximately 4-8 weeks depending on the patient's prescribed CRT plan). Patients will be recruited sequentially into either the Phase 2b or the Phase 3 part of the study. The VOICE trial’s primary endpoint is the occurrence of SOM, defined as any reporting of World Health Organization (WHO) Grade 3-4 OM, from the first day to the last day of chemoradiotherapy. An interim analysis will be conducted when Phase 2b patients have either completed their CRT or discontinued from the study. The Data Monitoring Committee (DMC) will review the Phase 2b efficacy and safety data at the interim analysis and will make a recommendation on proceeding with the Phase 3 part of the study. This trial design will allow Monopar to quickly proceed to Phase 3 if the Phase 2b criteria have been met, subject to Monopar's ability to raise additional funding or find a suitable pharmaceutical partner.