Knowing all you can about clinical trials can help you feel better when deciding whether or not to take part in one. The benefit the doctors look for depends on the goal of the treatment. Principal Investigator: Horst Klueppelberg, Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma (NCT03682796) Principal Investigator: Dr. Tomislav Dragovich, A Phase 1 Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (NCT02964013) Principal Investigator: Rajneesh Nath, A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma (NCT02343042) They take place after a new treatment has been … The NCI launched the CTSU in 1999 to streamline and harmonize support services for phase three Cooperative Group cancer clinical trials funded by the NCI. Phase I. Principal Investigator: Jiaxin Niu, A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial (NCT03773302) This will either be a dummy treatment (a placebo) or a standard treatment already in use. Principal Investigator: Santosh Rao, Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response Among Bladder Cancer Patients Receiving Neoadjuvant Chemotherapy (NCT03739177) I had thought that there were just three phases but it turns out that there are five, at least when it comes to cancer treatments, with just the middle three getting the most attention. A Phase I/II Study of HB-201 Monotherapy or in Combination with Nivolumab in Patients with Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers, For life-threatening emergencies, find the nearest emergency room, Gastrointestinal Cancer (Pancreatic, Colorectal, Gastric, Liver, Biliary and Neuroendocrine Cancers), Gynecologic Cancer (Cervical and Ovarian Cancers), Myeloproliferative Neoplasm (MPN) or Myelodysplastic Syndrome (MDS). Principal Investigator: Jiaxin Niu, BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments (NCT03056755) Principal Investigator: Jiaxin Niu Clinical trials testing potential medical products are commonly classified into four phases. The sponsor provides the drug and medical oversight. Clinical trial treatments typically consist of several phases, with each phase focused on a different purpose. Principal Investigator: Shakeela Bahadur Principal Investigator: Dr. Jiaxin Niu, "A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer" (NCT04123366) However, the new drug is rarely compared to the current (standard-of-care) drug that is used. The average length of a Phase III clinical trial can vary, ranging from one to four years or longer. Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy (NCT02945579) When the first cohort receives a dose of the new drug, doctors may collect blood or urine samples to … Here, we will focus on the first of the 4 phases of clinical trials. Early 3+3 Trial Dose-Escalation Phase I Clinical Trial Design and Suitability for Immune Checkpoint Inhibitors. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT04045795) © 2016 MPN Cancer Connection. Phase 2 clinical trials build on the results of phase 1 by testing the method on participants with the health condition targeted in the study. Principal Investigator: Stephanie Byrum Principal Investigator: Chinedu Mmeje, A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation (NCT03684811) For example, phase 2 clinical trials will begin to focus on a specific type of cancer, such as acute myeloid leukemia or glioblastoma, or a specific neurodegenerative disease like Alzheimer’s disease. Principal Investigator: Michael Stanek, A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors (NCT03170960) Principal Investigator: Jiaxin Niu, An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors (NCT03767348) It is important to understand what is involved before you give consent to take part. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen. Principal Investigator: Jiaxin Niu Principal Investigator: Dr. Jiaxan Niu, Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (NCT03175224) Phase 4 trials look at long-term safety and effectiveness. Prospective Registry of Breast Cancer Patients with Axillary Nodal Metastases Identified During If a new drug is successful in an early phase then it will proceed to the next phase. Principal Investigator: Jiaxin Niu. Principal Investigator: Sumit Madan, A Phase 1, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients With Advanced Solid Tumors and Hematologic Malignancies (NCT03886831) Randomised trials. A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer (NCT03983395) These phases are defined by the FDA, Food and Drug Administration. Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Type 1 Von Willebrand Disease: The VWD Minimize Study (NCT02606045) Principal Investigator: Shakeela Bahadur, A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies (NCT03598608) At first, very few people receive the medicine being studied. Do NOT follow this link or you will be banned from the site! The goal of Phase IV trials is to continue studying any side effects of a new treatment. Principal Investigator: Santosh Rao, A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011) (NCT03898180) Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02) (NCT03975647) Principal Investigator: Horst Klueppelberg, A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO-501, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL AND FOLLICULAR LYMPHOMA (NCT03939026) The past trials consist of three Phase I clinical trials and one Phase IIb clinical trial. This helps to avoid bias in the clinical trial. Molecular Tumor Board. A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC) (NCT03780517) A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects with Relapsed/Refractory HPV16+ Cancers (NCT03912831) Several dose-escalation designs based on mathematical modeling of the dose-toxicity relationship have been developed. You can ask the research nurse or doctor any questions you have. A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With >/=1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy (NCT02954874) Purpose: Increased β-adrenergic receptor (β-AR) signaling has been shown to promote the creation of an immunosuppressive tumor microenvironment (TME). Principal Investigator: Fade Mahmoud, A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV) to Evaluate Daratumumab Retreatment (NCT03871829) If a new drug is successful in an early phase then it will proceed to the next phase. I find it very encouraging that a search of clinicaltrials.gov shows over 270 clinical trials on Myeloproliferative Neoplasm, MPN with recruiting status. You may have to travel to take part in a trial. Principal Investigator: Dr. Lida Mina, A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy 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 (NCT01872975) Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. The average length of a Phase IV clinical trial is usually shorter than Phase III so typically fewer than four years. Principal Investigator: Lida Mina Development of new cancer drugs and treatment strategies occurs in four phases. Principal Investigator: Dr. Archan Shah, A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006) (NCT03483103) The following list shows the purpose of each phase and the number of patients that participate. Phase I trials usually include 15 to 30 patients, divided into small groups called cohorts. With combined phases, there is a seamless transition between trial phases, which may allow research questions to be answered more quickly or with fewer patients in the study. Principal Investigator: Matthew Ulrickson, A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma (NCT03677141) Information covering the basics of cancer clinical trials, including what they are, where they take place, and the types of clinical trials. Principal Investigator: Dr. Jiaxin Niu, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG‐Naïve High‐Grade Non‐Muscle Invasive Bladder Cancer (NCT03091660) ), It depends on the trial. The number of participants is 15-30. FT-7051 is a selective CREB-binding protein/E1A binding protein p300 (CBP/p300) inhibitor and co-activator of androgen receptor (AR). Phase II Clinical Trials. These trials usually involve a small number of patients for whom other standard therapies have failed or no known alternative therapy is available. A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somato-statin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). Principal Investigator: Lida Mina The conduct of clinical trials is also governed by further national laws and guidelines, which are discussed below. Scientific literature and results from early phase clinical trials suggest there may be a survival benefit in late-stage advanced / metastatic patients who are treated with masitinib. Drug is processed in the body and how it affects the body as few as a.... 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