CRLX101 Clinical Trials
The Phase 1/2a clinical trial was conducted at the City of Hope National Medical Center, the Translational Genomics Research Institute and San Juan Oncology Associates. Patients who were entered had refractory and resistant solid tumor cancer of various types, including pancreatic cancer, ovarian cancer and non small cell lung cancer (NSCLC). A total of 62 patients received treatment. Bi-weekly dosing was generally well tolerated with myelosuppression being the dose-limiting toxicity. Best overall response was stable disease in 28 patients (64%) treated at the maximum-tolerated dose (MTD) and 16 (73%) of a subset of NSCLC patients. Median progression-free survival (PFS) for patients treated at the MTD was 3.7 months and for the subset of NSCLC patients was 4.4 months. These combined phase 1/2a data demonstrate encouraging safety, pharmacokinetic, and efficacy results. A randomized Phase 2 trial is underway in non-small cell lung cancer in Russia and the Ukraine. In addition, a Phase 2 study of CRLX101 in recurrent ovarian/tubal/peritoneal cancer is underway and a Phase 1b/2a study of CRLX101 in combination with the angiogenesis inhibitor bevacizumab in renal cell carcinoma is underway at the Abramson Cancer Center of the University of Pennsylvania. A Phase 2 trial of CRLX101 as a monotherapy is also underway at the City of Hope Medical Center in patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that cannot be removed by surgery.
Read more about this topic: CRLX101
Famous quotes containing the word trials:
“... all the cares and anxieties, the trials and disappointments of my whole life, are light, when balanced with my sufferings in childhood and youth from the theological dogmas which I sincerely believed, and the gloom connected with everything associated with the name of religion, the church, the parsonage, the graveyard, and the solemn, tolling bell.”
—Elizabeth Cady Stanton (1815–1902)