Colorectal Neoplasms study with RNA-Seq, WGS data on dbGaP (31 participants)

phs002833 — A Phase 2 Study of Lamivudine in Patients with p53 Mutant Metastatic    Colorectal Cancer

<p>This was an open-label, single-arm Phase II study of lamivudine in patients who had progressed on systemic therapy for advanced colorectal cancer with <a href="https://www.ncbi.nlm.nih.gov/gene/?term=TP53">TP53</a> mutations. The phase II study had a two-stage design, with a target accrual of 20 evaluable patients for the first stage and a total of 32 patients for the whole study. The first 9 patients were treated with lamivudine at 150 mg PO bid continuously for 28-day cycles. Subsequent patients (10-32) received a higher dose of 600 mg PO bid continuously for 28-day cycles. Tumor assessments were performed every 8 weeks until documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) or drug intolerance. Whole genome sequencing (WGS) and total RNA-seq were performed on pre- and post- treatment biopsies on this trial.</p>