Trial & Business Updates:

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Priority Lists

Activations

S1310Phase II

Memorandum - Distribution for IRB Review Only

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
Study Coordinator(s)Richard D. Kim, M.D., Anthony El-Khoueiry, M.D.
ParticipantsMembers, NCORP, Affiliates

Closures

Amendments, Revisions, Memoranda

JMA17Phase III Intergroup

Memorandum

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 CodesNR
Study Coordinator(s)Silvana Martino, D.O.
S0605Phase II

Memorandum - CC-5013 Safety Report

A Phase II Study of Lenalidomide (Revlimid®) (NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Action CodesER
Study Coordinator(s)Mikkael A. Sekeres, M.D., M.S., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0777Phase III Intergroup

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 CodesER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S1117Phase II Intergroup

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 CodesER
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1216Phase III

Memorandum - Master Forms Set Update

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Action CodesIP, AC, FBR
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY
S1216Phase III

Revision #1

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Action CodesIP, AC, FBR
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY

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