About this trial
This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.
Eligibility criteria
Qualifiers
Subjects with cancer for which there remains ongoing questions regarding clinical effectiveness and/or cost effectiveness regarding a therapeutic agent
Eastern Co-operative Group (ECOG) 0-2
Life expectancy of at least 12 weeks
Adequate hematologic and end organ function for drug treatment per the clinician's assessment
Disqualifiers
Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to enrollment.
Inability to complete quality of life questionnaires
Pregnancy or breastfeeding.
Any significant cardiovascular disease, comorbidity (i.e. recent major infection, HIV, tuberculosis) or major surgical procedure within 21 days that in the opinion of the investigator renders the proposed treatment unsafe.
Trial design
Treatments tested in this trial
- QOL - quality of life
- Radiographic or laboratory evaluation