The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
Phase I
9591: A Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients with Hepatic Dysfunction. University Health Network-Princess Margaret Hospital; Siu, Lillian L. (416) 946-2911
Phase I/II
9525: An Open Label, Two-Part, Phase Ib/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor Trametinib and the BCL2-Family Inhibitor Navitoclax (ABT-263) in Combination in Subjects with KRAS Mutation-Positive Advanced Solid Tumors. Dana-Farber Cancer Institute; Corcoran, Ryan Bruce. (617) 726-8599
Phase II
A091302: Randomized Phase II Study of Sorafenib with or Without Everolimus in Patients with Radioactive Iodine Refractory Hürthle Cell Thyroid Cancer. Alliance for Clinical Trials in Oncology; Sherman, Eric Jeffrey. (646) 888-4234
Phase II/III
GOG-0281: A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer. NRG Oncology Foundation, Inc.; Gershenson, David M. (713) 745-2565
NRG-HN001: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA). NRG Oncology Foundation, Inc.; Lee, Nancy Y. (212) 639-3341
Phase III
A221301: Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC). Alliance for Clinical Trials in Oncology; Navari, Rudolph Modesto. (574) 631-8898
Pilot Phase
ARET12P1: A Multi-Institutional Feasibility Study of Intra-Arterial Chemotherapy Given in the Ophthalmic Artery of Children with Retinoblastoma. Children’s Oncology Group. Chintagumpala, Murali Mohan. (832) 822-4200
Other Phases
AALL13B12-Q: Analysis of Cyclin-Dependent Kinase 5 (Cdk5) Expression and Activity in Childhood ALL. Children’s Oncology Group; Pateva, Irina Boyanova. (216) 844-3345
ANBL13B7-Q: Risk Stratification of Stage 4 Neuroblastomas Using a Three-Gene Ratio Score. Children’s Oncology Group; Axelson, Hakan. +46462226434
E1608T3: Autoimmune Regulator as a Genetic Determinant of Response to Anti-CTLA4 Antibody Immunotherapy. ECOG-ACRIN Medical Research Foundation, Inc.; Su, Maureen A. (919) 966-0259
NSABP-C08-CS2: Molecular Correlates of Outcomes in Clinical Trials of Colon Cancer. NRG Oncology Foundation, Inc.; Chan, Andrew T. (617) 726-7802
RTOG-TRP-147: Molecular Markers of Anaplastic Gliomas. NRG Oncology Foundation, Inc.; Chakravarti, Arnab. (614) 293-3241
RTOG-TRP-220: Toxicity Profiling: Creating Novel Paradigms to Personalize Cancer Treatment. NRG Oncology Foundation, Inc.; Armstrong, Terri Sue. (713) 500-2044
SWOG-S0800A-SWOG-ICSC: Whole Exome Sequencing of DNA From Pre-Chemotherapy Needle Biopsies of Triple Negative and Inflammatory Breast Cancers Enrolled on the S0800 Trial. SWOG; Pusztai, Lajos. (203) 737-6858
SWOG-S9313C-SWOG-ICSC: Evaluation of BRCAness as Prognostic Marker in Triple-Negative Breast Cancer Patients Treated with Adjuvant Anthracycline-Based Chemotherapy on INT-0137 (SWOG 9313) Trial. SWOG; Sharma, Priyanka. (913) 588-3375
