Trial & Business Updates:

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Priority Lists

Activations

Closures

Amendments, Revisions, Memoranda

JMA17Phase III Intergroup

Memorandum 1 of 2 - Letrozole Safety Reports

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Action CodesER, NR
Study Coordinator(s)Silvana Martino, D.O.
JMA17Phase III Intergroup

Memorandum 2 of 2 - Drug Resupply

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Action CodesER, NR
Study Coordinator(s)Silvana Martino, D.O.
OV21Phase II-III

Revision #1

A Phase II/III Study of Intraperitoneal (IP) plus Intravenous (IV) Chemotherapy versus IV Carboplatin plus Paclitaxel in Patients with Epithelial Ovarian Cancer Optimally Debulked at Surgery following Neoadjuvant Intravenous Chemotherapy - NCIC-CTG
Study Coordinator(s)Deborah Armstrong, M.D.
ParticipantsMembers, NCORP, Affiliates
S0910Phase II

Memorandum - Epratuzumab Safety Reports

A Phase II Study of Epratuzumab in Combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory Precursor B-cell Acute Lymphoblastic Leukemia
Action CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Steven E. Coutre, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S1005Phase II

Memorandum - MK-2206 Safety Report

A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
Action CodesER
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D.
ParticipantsMedical Oncologists, Members, NCORP, Affiliates
S1007Phase III Intergroup

Memorandum - Revised Forms

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action CodesIP, AC, ER, NR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1007Phase III Intergroup

Revision #6

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action CodesIP, AC, ER, NR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1014Phase II

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 CodesER
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1115Phase II

Memorandum 1 of 2 - AZD6244 Safety Report

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 CodesER
Study Coordinator(s)Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1115Phase II

Memorandum 2 of 2 - MK-2206 Safety Report

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 CodesER
Study Coordinator(s)Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1207Phase III

Funding Memorandum

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. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1211Phase I-II

Revision #1

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesIP, AC, ER
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists

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