A Phase I study of PMR-116 in Patients with Advanced Malignancies
- Conditions
- Cancer - Any cancerAdvanced solid tumours
- Registration Number
- ACTRN12620001146987
- Lead Sponsor
- Pimera Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 24
•Ability to understand and be willing to sign an informed consent form.
•MYC positive, histopathologically confirmed, locally advanced or metastatic cancer (solid tumour) for which all available standard of care treatment options has been exhausted or refused and for which at least one lesion is measurable.
•Most recent chemotherapy treatment at least 3 weeks, or monoclonal antibody treatment at least 4 weeks, or allogeneic stem cell transplantation at least 24 weeks or radiation therapy at least 3 weeks prior to starting treatment with PMR-116.
•Males and females aged over 18 years
•Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
•Adequate liver and renal function as evidenced by pathology test results
•No recent major surgery at least 4 weeks prior to starting treatment with PMR-116
•Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
•Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion.
•Be willing to use protective measures against sun exposure and avoid the use of tanning salons and tanning beds
•Have an estimated life expectancy of at least 3 months.
•Dose Expansion only: Have a site of disease amenable to biopsy and be willing to undergo a biopsy prior to and during treatment with PMR-116
•Receiving any concurrent anti-cancer therapy
•Adverse Events from prior treatments which have not recovered to at least a mild (Grade 1) severity
•Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable with no CNS surgery or radiotherapy within 28 days prior to the first dose of PMR-116
•Any uncontrolled illness that would limit compliance with study requirements
•Any uncontrolled infection
•Known Human Immunodeficiency Virus (HIV) infection
•Active hepatitis B or hepatitis C infection
•Pregnant or breast feeding
•Unable to swallow oral medications
•Gastrointestinal conditions that could affect absorption of PMR-116
•Evidence of abnormal cardiac function
•Prior treatment with an RNA polymerase I inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method