None listed
Conditions
Brief summary
This study is evaluating the tolerability, safety and pharmacokinetics of Oral Monepantel (MPL) in patients with advanced solid tumours that do not respond to standard treatments. Who is it for? You may be eligible to joint this study if you have progressing and unresectable tumours, and have a life expectancy of greater than three months. All standard treatments need to have been exhausted or are contraindicated. Study details Following enrolment in the study, participants will receive an oral liquid dose of MPL once daily for 28 days. The first three participants enrolled in the study will receive 5mg /kg of body weight in each dose. If there are no toxicities or safety events observed in the first three participants, another three participants will be enrolled and receive 25 mg/kg of body weight in each dose. An additional three participants will be enrolled at 62.5 mg/kg body weight per dose if no toxicities/safety events are observed at 25 mg /kg body weight. If dose-limiting toxicities are observed at any dose level, an additional three participants will be enrolled at the same dose level, before the next dose level is initiated. This study design aims to determine whether there is a safe maximum dose that can be provided to patients with this condition. The results of the study will contribute towards the development of MPL as an anticancer treatment.
Interventions
Oral Monepantel (MPL) once daily for 28 days in escalating dose cohorts. Starting dose for the first cohort is 5 mg/kg bw, with planned dose escalations to 25 mg/kg bw and 62.5 mg/kg bw in subsequent dose cohorts. An additional dose cohort may be enrolled, dependent emerging results from earlier cohorts.
Study participants will also be required to complete a dosing diary card for each dose of study medication, and return any unused medication at the next clinic visit.
Following completion of
Oral Monepantel (MPL) once daily for 28 days in escalating dose cohorts. Starting dose for the first cohort is 5 mg/kg bw, with planned dose escalations to 25 mg/kg bw and 62.5 mg/kg bw in subsequent dose cohorts. An additional dose cohort may be enrolled, dependent emerging results from earlier cohorts. Study participants will also be required to complete a dosing diary card for each dose of study medication, and return any unused medication at the next clinic visit. Following completion of the 28 day treatment period study participants may opt to continue extension period, during which time they will continue to receive access to study medication. During the extension period, participants will be required to attend monthly outpatient visits for medical review, collection of blood samples, measurements of vital signs etc. At each monthly visit you will be required to return any unused study medication, and will be dispensed with enough study medication for one month of daily home dosing. Participants will receive standard medical care from their usual treating doctors/team. Participation in the Extension Period may occur indefinitely, or until the participant withdraws or experiences disease progression.
Sponsors
PharmAust Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female patients with progressing and unresectable tumours in whom all standard treatments have been exhausted or have been contraindicated. Life expectancy of at least 3 months, in the opinion of the Investigator.
Exclusion criteria
Recent treatment (i.e. within 14 days of screening) with any systemic anticancer therapy. Participants for whom standard therapy exists, and in the view of the Invesigator, is appropriate. Unresolved recovery from recent major surgery, or unresolved toxicity from recent radiotherapy.
Outcome results
None listed