PrECOG offers clinical trial oversight and management of all facets of sponsor-related responsibilities under an IND.
PrECOG collaborates with research groups and industry partners to explore innovative collaborations to achieve combined research interests. These research relationships offer different levels of partnership and are designed to facilitate research results. In these models, we align support of the study to achieve mutual developmental needs [e.g. data contributing to a potential regulatory filing or data request, publication, etc.]. To inquire further about research collaborations, please contact PrECOG.
Study Chair Dr. Craig Portell of the University of Virginia provides an overview of the PrE0405 trial for older adults with mantle cell lymphoma.
Study Chair Dr. Selina Luger of the University of Pennsylvania provides an overview of the PrE0905 trial for patients with AML with a FLT3 mutation.
|Study ID||Tumor||Study Status||Study Title||NCT ID|
|PrE0102||Breast||Completed||Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy https://clinicaltrials.gov/ct2/show/NCT01797120||NCT01797120|
|PrE0105||Breast||Completed||A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer https://clinicaltrials.gov/ct2/show/NCT00813956||NCT00813956|
|PrE0109 AFT-05||Breast||Active, Not Recruiting||AFT-05: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer https://clinicaltrials.gov/ct2/show/NCT02513394||NCT02513394|
|PrE0111 AFT-38||Breast||Recruiting||AFT-38: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer https://clinicaltrials.gov/ct2/show/NCT02947685||NCT02947685|
|PrE0113||Breast||Recruiting||A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study https://clinicaltrials.gov/ct2/show/NCT04215146||NCT04215146|
|PrE0204||GI||Completed||A Multi-institutional, Single arm, Two-stage Phase II Trial of Nab-paclitaxel and Gemcitabine for First-line Treatment of Patients with Advanced or Metastatic Cholangiocarcinoma https://clinicaltrials.gov/ct2/show/NCT02181634||NCT02181634|
|PrE0401||Lymphoma||Completed||Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma https://clinicaltrials.gov/ct2/show/NCT01889797||NCT01889797|
|PrE0403||Lymphoma||Recruiting||Phase II Study of Venetoclax (ABT-199/GDC-0199) in Combination With Obinutuzumab and Bendamustine in Patients With High Tumor Burden Follicular Lymphoma as Front Line Therapy https://clinicaltrials.gov/ct2/show/NCT03113422||NCT03113422|
|PrE0404||Lymphoma||Recruiting||A Phase I/II Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma https://clinicaltrials.gov/ct2/show/NCT03323151||NCT03323151|
|PrE0405||Lymphoma||Recruiting||Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age https://clinicaltrials.gov/ct2/show/NCT03834688||NCT03834688|
|PrE0501||Thoracic||Completed||A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination With Docetaxel and Carboplatin Followed by Placebo or Maintenance Therapy With Vandetanib in Patients With IIIb, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) https://clinicaltrials.gov/ct2/show/NCT00687297||NCT00687297|
|PrE0502||Thoracic||Completed||An Open-Label, Randomized, Phase IIIb Trial Evaluating The Efficacy And Safety Of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression Of Disease In Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After First-Line Treatment With Bevacizumab Plus A Platinum Doublet-Containing Chemotherapy (MO22097) https://clinicaltrials.gov/ct2/show/NCT01351415||NCT01351415|
|PrE0504||Thoracic||Completed||A Phase I/II Study of Glembatumumab Vedotin in Patients With gpNMB-Expressing, Advanced or Metastatic Squamous Cell Carcinoma of the Lung https://clinicaltrials.gov/ct2/show/NCT02713828||NCT02713828|
|PrE0505||Thoracic||Active, Not Recruiting||Anti - Programmed Death – Ligand 1 Antibody, Durvalumab, in Combination with Chemotherapy for the First-Line Treatment of Unresectable Mesothelioma https://clinicaltrials.gov/ct2/show/NCT02899195||NCT02899195|
|PrE0506||Thoracic||Recruiting||DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma (DREAM3R) https://clinicaltrials.gov/ct2/show/NCT04334759||NCT04334759|
|PrE0801||GU||Completed||NEXT: Subsequent exposure to tyrosine kinase inhibition (TKI) at recurrence after adjuvant therapy in renal cell carcinoma (RCC) https://clinicaltrials.gov/ct2/show/NCT01649180||NCT01649180|
|PrE0807||GU||Active, Not Recruiting||Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer https://clinicaltrials.gov/ct2/show/NCT03532451||NCT03532451|
|PrE0901||Leukemia||Completed||Phase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults With Acute Myeloid Leukemia (AML) in Complete Remission https://clinicaltrials.gov/ct2/show/NCT01656252||NCT01656252|
|PrE0905||Leukemia||Recruiting||Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia https://clinicaltrials.gov/ct2/show/NCT03836209||NCT03836209|
|PrE1003||Multiple Myeloma||Completed||A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function https://clinicaltrials.gov/ct2/show/NCT00790842||NCT00790842|
Ideas for trials can be submitted to PrECOG for consideration by ECOG-ACRIN Cancer Research Group members in good standing, or other collaborators after discussions with PrECOG. Research ideas are developed and submitted to PrECOG by investigators as detailed study concepts. Once reviewed and approved, PrECOG will work to operationalize study concepts. The process for reviews is streamlined by parallel scientific [PrECOG/ECOG-ACRIN Cancer Research Group] and industry partner reviews. NCI review and approval is not required. Please contact PrECOG, to discuss any trial ideas.
Sites are selected to participate in PrECOG trials based on current research standing, prior study performance, experience, and study feasibility. Potential sites provide information for specific study requirements under confidentiality including projected enrollment, research facility information, etc. Site selection follows all applicable regulations required by sponsors and researchers. Sites are notified of selection to participate after this process is complete. To ask about your site participating in PrECOG trials, please contact PrECOG.