Open-to-Accrual Therapeutic Trials - Phase III


Phase III

Protocol ID

Official Title

PI Name

Lead CRC

Disease Site

Phase

2215-CL-0201  ClinicalTrials.gov:   NCT02752035

A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy J. Pantin Sandra Wall Acute Myeloid Leukemia II/III

EA6141  ClinicalTrials.gov:   NCT02339571

Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma S. Ghamande Inquiries Melanoma II/III

GOG-0286B  ClinicalTrials.gov:   NCT02065687

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer S. Ghamande Kelly Adams Endometrial Cancer II/III

RTOG-1216  ClinicalTrials.gov:   NCT01810913

Randomized Phase II/III Trials of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Celuximab for High-Risk Squamous Cell Cancer of the Head and Neck S. Ghamande Inquiries Head and Neck Squamous Cell Cancer II/III

2215-CL-0302  ClinicalTrials.gov:   NCT02927262

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission J. Pantin Sandra Wall Acute Myeloid Leukemia III

A011106  ClinicalTrials.gov:   NCT01953588

ALTernate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast Cancer NeoAdjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study S. Ghamande Inquiries Breast Cancer III

A011202  ClinicalTrials,gov:   NCT01901094

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3N1) Who have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy S. Ghamande Inquiries  Breast Cancer III

A051301  ClinicalTrials.gov:   NCT02443077

A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-cell Subtype S. Ghamande Inquiries Large C-Cell Lymphoma III

A081105 (ALCHEMIST)  ClinicalTrials.gov:   NCT02193282

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) S. Ghamande Inquiries Non-Small Cell Lung Cancer III

A221102  ClinicalTrials.gov:   NCT01573442

Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias S. Ghamande Inquiries Arthralgias III

CALGB-80702  ClinicalTrials,gov:   NCT01150045

A Phase III Trials of 6 Versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer S. Ghamande Kelly Adams Colon Cancer III

CLOVIS  ClinicalTrials.gov:   NCT02855944

A Phase 3 Milticenter, Open-label, Randomized Study of Rucaparib versus Weekly Paclitaxel in Patients with BRCA-like Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer S. Ghamande Donna Wheatley Ovarian, Fallopian Tube, or Primary Peritoneal Cancer III

E4512 (Alchemist)  ClinicalTrials.gov:   NCT02201992

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein S. Ghamande Inquiries  Non-Small Cell Lung Cancer III

EA5142  ClinicalTrials.gov:   NCT02595944

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers S. Ghamande Inquiries Non-Small Cell Lung Cancer III

EA6134  ClinicalTrials.gov:   NCT02224781

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 S. Ghamande Inquiries Melanoma III

GOG 3005/AbbVie  ClinicalTrials.gov:   NCT02470585

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serious Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer S. Ghamande Melissa James Ovarian, Fallopian Tube, or Primary Peritoneal Cancer III

GOG 3009/ADXS001-02  ClinicalTrials,gov:   NCT02853604

Phase 3 Study of ADXS11-001 Adminstered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV S. Ghamande Kelly Adams Cervical Cancer III

GOG 3012/PR-30-5017-C  ClinicalTrials.gov:   NCT02655016

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy S. Ghamande Kelly Adams Ovarian Cancer III

NRG-BR003  ClinicalTrials.gov:   NCT02488967

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer S. Ghamande Inquiries Breast Cancer III

NSABP-B-51  ClinicalTrials.gov:   NCT01872975

A Randomized Phase III Clinical Trial Evaluating Post-Masectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy S. Ghamande Inquiries Breast Cancer III

NSABP-B-52  ClinicalTrials,gov:   NCT02003209

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 S. Ghamande Inquiries Breast Cancer  III

NSABP-B-55  ClinicalTrials.gov:   NCT02032823

A Randomized, 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 BRCA 1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy S. Ghamande Inquiries Breast Cancer III

S0819  ClinicalTrials.gov:   NCT00946712

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) S. Ghamande Inquiries Non-Small Cell Lung Cancer III

S0931 (EVEREST)  ClinicalTrials.gov:   NCT01120249

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study S. Ghamande Inquiries Renal Cancer III

S1207  ClinicalTrials.gov:   NCT01674140

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy Plus or Minus One Year of Everolimus in Patients with High Risk, Hormone Receptor-Positive and Her2/neu Negative Breast Cancer S. Ghamande Inquiries Breast Cancer III

SOLO 3  ClinicalTrials.gov:   NCT02282020

A Phase III, Open Label, Randomized, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations  S. Ghamande Melissa James Ovarian Cancer III