Solid Tumor Trials
MBRCC Open Clinical Trials List – April 2015 Solid Tumor Multiple Malignancies Phase 1 D6020C00001 - A Phase 1, Open-label Study to Evaluate the Safety and Tolerability of MEDI0680 (AMP-514) in Combination with MEDI4736 in Subjects with Advanced Malignancies Manish Monga, MD; Carla Ross, RN Brain/CNS Adjuvant Phase 3 A221101 - A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with Glioblastoma Multiforme Javier Gonzalez, MD; Sylvia McEwuen, RN Breast Cancer Neo-Adjuvant Locally Advanced - Phase 3 A011202 - A Randomized Phase III Trial Evaluating The Role Of Axillary Lymph Node Dissection In Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy Jessica Partin, MD; Cortney Montgomery, RN NSABP-B52 - A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation Adham Salkeni, MD; Cortney Montgomery, RN 1 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – April 2015 NSABP-B51/RTOG-1304 - A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and PostLumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy Jessica Partin, MD; Cortney Montgomery, RN Adjuvant Phase 3 S1207- Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. Sobha Kurian, MD; Cortney Montgomery, RN Metastatic 1st Line ML28257 - An Observational Cohort Study of Treatment Patterns and Outcomes In Patients With HER2 Positive (HER2+) Metastatic Breast Cancer Adham Salkeni, MD; Cortney Montgomery, RN GO29227 - A randomized, Phase 2, Multicenter, Placebo -Controlled study of Ipatasertib (GDC-0068), an inhibitor of AKT, in combination with paclitaxel as front-line treatment for patients with metastatic triple-negative breast cancer. Adham Salkeni, MD; Cortney Montgomery, RN 2nd Line + Phase 1b/2 C31001 - A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant Adham Salkeni, MD; Cortney Montgomery, RN Phase 3 PUMA-NER-1301- A Study Of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine In Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens In The Metastatic Setting (NALA) Adham Salkeni, MD; Cortney Montgomery, RN 2 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – April 2015 Other A011104 - Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer Ginger Layne, MD; Cortney Montgomery, RN WVU011113 - Tissue Procurement for Laboratory Studies Involving Novel Therapies for Breast Cancer Hannah Hazard, MD; Cortney Montgomery, RN WVU011112 - Validation of a Novel Marker Associated with Risk for Delayed Chemotherapy-induced Vomiting (CIV) (Breast) Gerald Higa, PharmD; Karen Stauffer, RN WVU011513 - Automated breast ultrasound in the evaluation of occult sites of breast cancer in women with unilateral biopsy-proven breast cancer or highly suspicious breast lesion Ginger Layne, MD WVU011013 - Mastering Your Mind - Provide free evidence-based PST-OT and computerized cognitive training program for persons with cancertherapy-associated cognitive change. Anne Cronin, PhD WVU011414 - Title Time course of upper extremity functional recovery following mastectomy Anne Swisher, PhD Head and Neck Metastatic Phase 2 D4193C00001 - A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Manish Monga, MD; Toni Bulian, RN Adjuvant Locally Advanced - Phase 3 RTOG-0920 - A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer Manish Monga, MD; Toni Bulian, RN E1311 - A Randomized, Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence Manish Monga, MD; Toni Bulian, RN 3 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – April 2015 RTOG1216 - Randomized Phase II/III Trial of Surgery and Postoperavtive Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck Manish Monga, MD; Toni Bulian, RN Other WVU011614 - Pilot Study of Metformin (MF) in HNSCC (Head and Neck Squamous Cell Carcinoma) as Window Trial Design in Operable HNSCC to Investigate the Effects of MF Tumor Genotype and MF-genotype Interactions on Tumor Metabolism and Aniokis. Manish Monga, MD; Toni Bulian, RN Kidney (Renal Cell) Cancer Phase 2 ECOG1808 - A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features Thomas Hogan, MD; Carla Ross, RN Lung Cancer –NSCLC (Non Small Cell) Metastatic 1st Line Phase 2 E2511 - Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer Manish Monga, MD; Carla Ross, RN Phase 3 ECOG5508 - Randomized Phase III Study of Maintenance Therapy with Bevacizumab,Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC Mohammed Almubarak, MD; Carla Ross, RN 4 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – April 2015 2nd or 3rd Line D1532C00079 - A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) d-Sulfate) in Combination with Docetaxel, in Patients receiving second e treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB – IV) (SELECT-1) Mohammed Almubarak, MD; Carla Ross, RN 9090-14 - A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel versus Docetaxel Alone in Patients With Advanced NonSmall-Cell Lung Adenocarcinoma Manish Monga, MD; Carla Ross, RN Squamous Cell Phase 2/3 - 2nd Line S1400 - Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer. Manish Monga, MD; Carla Ross, RN Maintenance – Phase 3 ABI-007-NSCL-0003 - A Phase III,Randomized, Open-Label, Cross-Over, Multi-Center, Safety and Efficacy Study to Evaluate NABPaclitaxel(Abraxane) As Maintenance Treatment After Induction With NAB-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell NonSmall Cell Lung Cancer (NSCLC) Manish Monga, MD; Carla Ross, RN Melanoma ECOG3612 - A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma Manish Monga, MD; Carla Ross, RN Prostate RTOG 0924 - Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial Malcolm Mattes, MD; Toni Bulian, RN 5 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – April 2015 Contacts Principal Investigators Email Phone Mohammed Almubarak, MD [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] 304-293-4229 Miklos Auber, MD Alexander Chi, MD Anne Cronin, PhD Hannah Hazard, MD Javier Gonzalez, MD Gerald Higa, PharmD Thomas Hogan, MD Geraldine Jacobson, MD Sobha Kurian, MD Ginger Layne, MD Malcolm Mattes, MD Manish Monga, MD [email protected] [email protected] 304-293-4229 304-293-7826 304-293-0443 304-293-2380 304-293-3527 304-293-1461 304-293-4229 304-293-7227 304-293-4229 304-293-3091 304-293-9094 304-293-4229 Anne Swisher [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] Study Coordinators Email Phone Trish Beal, RN Toni Bulian, RN Sylvia McEwuen, RN [email protected] [email protected] [email protected] [email protected] [email protected] 304-293-0609 304-293-2633 304-293-1683 Jessica Partin, MD Adham Salkeni, MD Brent Steadman, MD Patricia Stoltzfus, MD Cortney Montgomery, RN Carla Ross, RN 304-293-7095 304-293-4229 304-293-3091 304-293-3091 304-293-1319 304-293-7375 304-581-1158 6 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
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