Priority Lists
Protocol Posting of
Activations
Activation
A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma
| Action Codes | FBR |
| Study Coordinator(s) | Bartosz Chmielowski, M.D., Ph.D |
| Participants | CTSU |
Activation
Molecular Analysis for Therapy Choice (MATCH)
| Action Codes | ER |
| Study Coordinator(s) | Victor Villalobos, MD, PhD |
| Participants | CTSU |
Closures
Permanent Closure effective 7/31/15
Prevention of Cataract and Age-Related Macular Degeneration with Vitamin E and Selenium - SELECT Eye Endpoints (SEE)
| Action Codes | ER |
| Study Coordinator(s) | William Christen, Sc.D., Robert Glynn, Sc.D., J. Michael Gaziano, M.D. |
| Participants | Institutions listed in protocol Appendix 19.5 |
| Closure Date | 2015-07-31 |
Temporary Closure effective 9/2/15
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
| Action Codes | NR |
| Study Coordinator(s) | D. Ross Camidge, M.D., Ph.D, Tianhong Li, M.D., Ph.D, Robert C. Doeble, M.D., Ph.D |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
| Closure Date | 2016-09-01 |
Amendments, Revisions, Memoranda
Memorandum - Fulvestrant Safety Report
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
| Action Codes | ER |
| Study Coordinator(s) | Rita S. Mehta, M.D., Kathy Albain, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU |
Memorandum - CC-5013 Safety Report
A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
| Action Codes | ER |
| Study Coordinator(s) | Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU |
Memorandum - Cetuximab Supply
A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
| Action Codes | NR |
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, CTSU Institutions in the United States |
Memorandum
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
| Action Codes | NR |
| Study Coordinator(s) | Jason A. Zell, D.O. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - Abiraterone Acetate Safety Reports
Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
| Action Codes | ER |
| Study Coordinator(s) | Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
Memorandum - ARQ 197 Safety Report
Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
| Action Codes | ER |
| Study Coordinator(s) | Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU |
Memorandum - IND Withdrawn
Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
| Action Codes | NR |
| Study Coordinator(s) | Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - CC-5013 Safety Report
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
| Action Codes | ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Memorandum - Timing of Section 15.1 Specimen Submission
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
| Action Codes | ER |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Memorandum
"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
| Action Codes | NR |
| Study Coordinator(s) | Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - Fulvestrant Safety Report
Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial In Postmenopausal Patients With Hormone-Receptor Positive Stage IV Breast Cancer.
| Action Codes | ER |
| Study Coordinator(s) | George Somlo, M.D., Halle C.F. Moore, M.D., Daniel F. Hayes, M.D. |
| Participants | NCORP, Affiliates, Members, Medical Oncologists, Surgeons |
Memorandum - Outpatient Administration Investigator Statement of Verification
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #4
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 3 - MEDI4736 Safety Report (for S1400A)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 2 of 3 - Palbociclib Safety Report (for S1400C)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 3 of 3 - New Investigator's Brochure AZD4547 (for S1400D)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required