Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on… (NCT02795156) | Clinical Trial Compass
CompletedPhase 2
Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations
United States100 participantsStarted 2016-09-28
Plain-language summary
With the increased availability of next-generation sequencing, oncologists are starting to incorporate genomic profiling into routine care of cancer patients. If a genomic alteration is identified during profiling, it could help guide the choice of therapy and improve treatment outcomes. This study will examine the anti-tumor activity of selected commercially available molecularly matched targeted therapies in patients who have failed first-line treatment for one of the following tumor types: non-small cell lung cancers; urothelial cancer; non-colon gastrointestinal cancers, and upper aerodigestive tract cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with a histologically or cytologically confirmed diagnosis of one of the following tumor types whose disease has progressed following one line of standard therapy and/or for which no standard treatment is available that has been shown to prolong survival:
✓. Non-small cell lung cancer
✓. Urothelial carcinoma
✓. Non-colon gastrointestinal cancers (including hepatobiliary, pancreatic, and gastroesophageal tumors)
. Two or more prior chemotherapy regimens in the metastatic setting.
✕. Most recent chemotherapy ≤ 3 weeks and \> Grade 1 chemotherapy-related side effects, with the exception of neuropathy (\> grade 2 excluded) and alopecia.
✕. Use of a study drug or targeted therapy ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of study treatment is required.
✕. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
✕. Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
✕. Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy. Enzyme-inducing anticonvulsants are contraindicated.
✕. Pregnant or lactating
✕. Acute or chronic liver, renal, or pancreas disease.