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
ADVL1314: A Phase 1 Study of Eribulin Mesylate (E7389, IND#116,292), a Novel Microtubule Targeting Chemotherapeutic Agent in Children with Refractory or Recurrent Solid Tumors (Excluding CNS), Including Lymphomas. COG Phase 1 Consortium; Schafer, Eric Stephen. (832) 825-4241
ADVL1315: A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# TBD) in Children with Recurrent or Refractory Solid Tumors. COG Phase 1 Consortium; Geller, James Ian. (513) 636-6312
Phase I/II
EA2131: A Phase I and Randomized, Double-Blinded Phase II Study of Nab-Paclitaxel/Gemcitabine Plus AZD1775 or Placebo in Treatment-Naïve Metastatic Adenocarcinoma of the Pancreas. ECOG-ACRIN Cancer Research Group; Chee, Cheng Ean. (216) 844-8609
Phase II
9604: Perfusion CT as Predictive Biomarker in a Phase II Study of Ziv-Aflibercept in Patients with Advanced Pancreatic Neuroendocrine Tumors. MD Anderson Cancer Center; Yao, James C. (713) 792-2828
S1300: A Randomized, Phase II Trial of Crizotinib Plus Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive Non-Squamous NSCLC Patients Who Have Progressed Systemically After Previous Clinical Benefit From Crizotinib Monotherapy. SWOG; Camidge, David Ross. (720) 848-0449
S1320: A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma. SWOG; Algazi, Alain Patrick. (415) 353-7552
Phase II/III
ARST1321: Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613). Children’s Oncology Group; Weiss, Aaron Robert. (207) 396-7565
S1400: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363
S1400A: A Phase II/III Randomized Study of MEDI4736 Versus Chemotherapy as Second Line Therapy for Patients with Squamous Cell Lung Cancer and No Matching Biomarkers. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363
S1400B: A Phase II/III Randomized Study of GDC-0032 Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363
S1400C: A Phase II/III Randomized Study of Palbociclib Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363
S1400D: A Phase II/III Randomized Study of AZD4547 Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363
S1400E: A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363
Phase III
AMC-A01: ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study. AIDS-Associated Malignancies Clinical Trials Consortium; Palefsky, Joel. (415) 476-1574
NSABP-B-55: A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy. NRG Oncology; Geyer, Charles Edward. (804) 628-6435
Other Phases
A151202: Development of Predictive and Prognostic Blood-Based Biomarkers in Men with Castration-Resistant Prostate Cancer in CALGB 90401. Alliance for Clinical Trials in Oncology; George, Daniel James. (919) 668-4615
AAML14B5-Q: Efficacy of CFB-SMMHC Inhibitor in Inv16 AML Cells. Children’s Oncology Group; Castilla, Lucio H. (508) 856-3281
AOST14B1-Q: Probing the Alternative Lengthening of Telomeres ALT Pathway in Osteosarcoma. Children’s Oncology Group; Flynn, Rachel Litman. (617) 638-4346
GOG-ELD1301: Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers. NRG Oncology; Ahmed, Amina. (847) 723-8180
