Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Dr. AV Cancer Institute of Personalized Cancer Treatment and Research
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients = 18 years of age, who have agreed to receive either molecularly targeted matched treatment based on molecular profiling analysis or conventional anti-cancer treatment in routine clinical practice as per their discussion with the treating physician and have provided written informed consent for participation in the study. Patients with incurable malignancies. Patients with cancer of unknown primary, or a rare tumor with no approved therapies. Patients with cancers of hereditary in nature Patients must have the following for a diagnosis/disease status: Relapsed or refractory advanced/metastatic disease, Actionable alterations determined by molecular profiling Molecular profiling (including one or more technologies but not limited to NGS, FISH, IHC, PCR, Microarray, and histopathology) for tumor and/ or blood analysis results should be available with all patients. Known disease status post one or more unmatched systemic therapy regimens. Patients must have a measurable disease for malignancies: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as =20 mm with conventional techniques or as =10 mm with spiral CT scan, PET-CT, MRI, or calipers by clinical exam or liquid biopsy showing the ctDNA fraction. ECOG Performance Status 0-2. New York Heart Association (NYHA) Functional Classification I-II. Adequate organ and marrow function At the time of treatment, patients should be off other anti-tumor agents for at least 5 half-lives of the agent or 3 weeks from the last day of treatment, whichever is shorter. Patients must be off prior antibody therapy for at least 3 half-lives before starting treatment. Able to swallow and retain oral medication if needed. Female patients of childbearing potential must have a negative serum/ urine pregnancy test and agree to use at least one form of pregnancy prevention during the study and for at least one month after treatment discontinuation. For the purposes of this study, the child-bearing potential is defined as all female patients that were not in post-menopause for at least one year or are surgically sterile. Male patients must use a form of barrier pregnancy prevention approved by the investigator/ treating physician during the study and for at least one month after treatment discontinuation.
Exclusion criteria
Exclusion criteria: Severe or uncontrolled medical disorder Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the response rate (RR) in patients who receive molecularly targeted matched treatment based on molecular profiling analysis as compared to conventional anti-cancer treatmentTimepoint: 4 weeks, 8 weeks, 12 weeks, 24 weeks, 48 weeks as per routine clinical practice | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the clinical benefit rate (CBR), duration of response (DoR), overall survival (OS), progression-free survival (PFS), and toxicity in patients who receive molecularly targeted matched treatment based on molecular profiling analysis as compared to conventional anti-cancer treatmentTimepoint: 4 weeks, 8 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks, 156 weeks, 208 weeks, and 260 weeks as per routine clinical practice | — |
Countries
India
Contacts
Public ContactDr Amit Verma
Dr. AV Cancer Institute of Personalized Cancer Treatment and Research
Outcome results
None listed