Cancer Clinical Trials

• Acute Meyloid eukemia
  • A Phase III, double-blind, placebo-controlled, multicenter, randomized study of pracinostat in combination with azacitidine in patients 18 years or older with newly diagnosed acute myeloid leukemia unfit for standard induction chemotherapy. Helsinn PRAN-16-52 | Jatin Rana, MD
• Essential Thrombocythemia
  • Advanced Solid Tumors or LymphomaECOG NCI-MATCH:  Targeted drug therapy directed by genetic testing in treating patients with advanced refractory tumors.  NCT#02465060 | Borys Hrinczenko, MD
• Benign Hematology
  • ALEXION PAROXYSMAL NOCTURNAL HEMOGLOBINURIA REGISTRY: A multi-center, multi-national, observational registry with enrollment of patients who are diagnosed with PNH and also PNH patients not receiving Soliris therapy. NCT#01374360 | Borys Hrinczenko, MD
• Breast
  • ALLIANCE A011401: Randomized Phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer. For HER2 negative, and ER/PR positive or negative breast cancer. NCT#02750826 | Jatin Rana, MD

   

  • BIG TEN BTCRC-BRE15-016: A single arm Phase II study of palbociclib in combination with tamoxifen as first line therapy for metastatic hormone receptor positive breast cancer.  NCT#02668666 | Jatin Rana, MD

   

  • BIG TEN BTCRC-BRE16-042: A Phase II study of pembrolizuamb plus fulvestrant in hormone receptor positive, HER-2 negative advance/metastatic breast cancer patients. NCT#03393845 | Jatin Rana, MD

   

  • NRG B-55: A randomized, double-blind, parallel group, placebo-controlled multi-center Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment AND neoadjuvant OR adjuvant chemotherapy.  NCT#02032823 | Jatin Rana, MD

   

  • NSABP B-59: A randomized, double-blind, Phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo in patients with triple-negative breast cancer followed by adjuvant continuation of atezolizumab or placebo. NCT#03281954 | Jatin Rana, MD

   

  • SWOG S1207: 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. NCT#01674140 | Jatin Rana, MD

   

  • SWOG S1418 (NRG BR006):  A randomized, Phase III trial to evaluate the efficacy and safety of MK-3475 as adjuvant therapy for triple receptor-negative breast cancer with > 1 cm residual invasive cancer or positive lymph nodes (>pN1mic) after neoadjuvant chemotherapy. NCT#02954874 | Jatin Rana, MD
• Bladder
  • SWOG S1605: A PhaseII trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer. NCT#02844816 | Jatin Rana, MD 
• Colon
  • ALLIANCE A021502: Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with Stage III colon cancer and deficient DNA mismatch repair. NCT#02912559 | Jatin Rana, MD
• Essential Thrombocythemia
  • Incyte INCB-MA-MF-401:  Prospective, longitudinal, non-interventional study of disease burden and treatment of patients with low-risk myelofibrosis OR high-risk essential thrombocytemia (ET) OR ET patients receiving ET-directed therapy (MOST Trial). NCT#02953704 | Borys Hrinczenko, MD
• Gastric, Gastro-Esophageal Junction
  • BIG TEN BTCRC-GI15-015: A Phase II study of FOLFOX combined with nab-paclitaxel (FOLFOX-A) in the treatment of metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma. NCT#03283761 | Jatin Rana, MD
• Lung
  • ALLIANCE A221504: A randomized, double-blind, placebo-controlled pilot study of an oral, selective peripheral opioid receptor antagonist in advanced non-small cell lung cancer (Adenocarcinoma) Stage IIIB or Stage IV NCT#02912559 | Borys Hrinczenko, MD

   

  • BIG TEN BTCRC-LUN16-081: A Phase II study of consolidation immunotherapy with nivolumab and ipilimumab or nivolumab alone following concurrent chemoradiotherapy for unresectable Stage IIIA/IIIB non-small cell lung cancer. NCT#03285321 |  Borys Hrinczenko, MD

   

  • EMD SERONA EMR200647-001 (for non-small cell lung cancer): A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0011359C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.  NCT#01772004 |  Borys Hrinczenko, MD
• Lymphoma
  • Incyte INCB39110-206: An open-label phase ½ study of INCB039110 (Itacitinib) in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma. NCT#02760485 | Jatin Rana, MD
• Multiple Myeloma
  • ECOG E1A11:  Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE) NCT01863550 | Jatin Rana, MD

   

  • ECOG NCI-MATCH:  Targeted drug therapy directed by genetic testing in treating patients with advanced refractory tumors NCT#02465060 | Borys Hrinczenko, MD
• Millennium C16029
  • A Phase 2/3, randomized, open-label study comparing oral ixazomib/dexamethasone and oral pomalidomide/dexamethasone in relapsed and/or refractory multiple myeloma. NCT#03170882 | Jatin Rana, MD
• Myelodysplastic Syndrome (MDS) or Myelproliferative Overlap Disorder
  • CELGENE CONNECT MDS/AML REGISTRY: An observational study of patients with newly diagnosed (within 2 months) MDS or AML. Patients are excluded it they have received treatment with active agents for MDS or AML prior to ICF date. Supportive care treatments are allowed.  NCT#01688011 | Borys Hrinczenko, MD

   

  • NHLBI MDS: The National Myelodysplastic Syndromes (MDS) Study.  A multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). NCT#02953704 | Jatin Rana, MD
• Myelofibrosis
  • Incyte INCB-MA-MF-401:  Prospective, longitudinal, non-interventional study of disease burden and treatment of patients with low-risk myelofibrosis OR high-risk essential thrombocytemia (ET) OR ET patients receiving ET-directed therapy (MOST Trial) NCT#02953704 | Borys Hrinczenko, MD
• Prostate
  • NRG-GU006: A phase II, double-blinded, placebo-controlled randomized trial of salvage radiotherapy with or without enhanced anti-androgen therapy with apalutamide in recurrent prostate cancer. NCT#03371719 | Jatin Rana, MD
• Symptom Management
  • WYATT SMART TRIAL: Symptom Management (Strategies) Among Cancer patients with possible Reflexology, or Meditative Practices (gentle yoga, meditation and breathing exercises) NCT#02759146 | contact ph.: (517) 975-9547