65 studies found

A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually and despite effective antivirals causes significant morbidity and mortality (estimated 24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S) but in contrast...

Dabrafenib, Trametinib, and Navitoclax in Treating Patients With BRAF Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), toxicity, and safety profile of navitoclax when given in combination with dabrafenib and trametinib in patients with BRAF-mutant solid tumors. (Phase I) II. To estimate the complete response (CR) rate in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, and...

DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

PRIMARY OBJECTIVES: I. To determine whether binary changes (increase versus [vs.] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS). SECONDARY OBJECTIVES: I. To determine whether the baseline pre-treatment rCBV measure alone is associated with OS. II....

Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

PRIMARY OBJECTIVES: I. To estimate the overall response rates of olaparib in subjects with recurrent/progressive IDH1/2-mutant solid tumors, who will be recruited to 3 cohorts: a. glioma, b. cholangiocarcinoma, c. other solid malignant tumors. SECONDARY OBJECTIVES: I. To estimate the distribution of progression free survival (PFS) of olaparib in adults...

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Medically Inoperable Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC). The primary study hypotheses are: 1. SBRT plus pembrolizumab prolongs Event-free Survival...

MDM2 Inhibitor AMG-232 and Decitabine in Treating Patients With Relapsed, Refractory, or Newly-Diagnosed Acute Myeloid Leukemia

PRIMARY OBJECTIVES: I. To evaluate the toxicities of MDM2 inhibitor AMG-232 (AMG-232) in combination with decitabine (20 mg/m^2 for 10 days), and to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of AMG-232 in combination with a standard dose of decitabine. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic...

Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

PRIMARY OBJECTIVES: I. To determine the progression-free survival with AZD9291 (osimertinib) plus bevacizumab compared to AZD9291 (osimertinib) alone. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of the combination of AZD9291 (osimertinib) and bevacizumab. II. To evaluate the time to progression in the central nervous system (CNS) with AZD9291...

Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer

PRIMARY OBJECTIVES: I. Identify how patients with cancer are obtaining nutrition to support medical management. SECONDARY OBJECTIVES: I. Examine associations of gastrointestinal side effects with specific diagnoses and respective medical therapies. II. Understand how patients access information regarding nutritional supplements. III. Evaluate patient satisfaction with currently available oral nutritional supplements...

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the efficacy and safety of BGB-A317 as second line treatment in patients with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

Study Outline: - All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. - Patients who do not have a sentinel lymph node identified will not be registered/randomized to...

Savolitinib in Treating Participants With MET Amplified Metastatic or Unresectable Colorectal Cancer

PRIMARY OBJECTIVES: I. To estimate the objective response rate (ORR) of savolitinib in patients with MET amplified metastatic colorectal cancer (CRC). SECONDARY OBJECTIVES: I. To describe the clinical activity (duration of response, progression free survival [PFS]) of savolitinib in patients with MET amplified metastatic CRC. II. To describe the toxicities...

Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine

In Phase 1 of the study, the dose-limiting toxicity (DLT) assessment period will be 5 weeks---one-week run-in at each dose level of intravenous GP-2250 monotherapy followed by a full cycle of GP-2250 plus gemcitabine (3 weeks on and 1 week off). Single-subject cohorts will be enrolled until the occurrence of...

Olaparib in Treating Patients With Metastatic or Advanced Urothelial Cancer With DNA-Repair Defects

PRIMARY OBJECTIVES: I. To evaluate the efficacy of olaparib in two cohorts of patients with metastatic/advanced urothelial carcinoma (UC) pre-selected by deoxyribonucleic acid (DNA)-repair defects as measured by overall response rate (ORR). SECONDARY OBJECTIVES: I. To describe the effect of therapy on progression free survival (PFS). II. To describe the...

Phase 1b Study to Evaluate ATP128, With or Without BI 754091, in Patients With Stage IV Colorectal Cancer

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients...

A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6

INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. (Nonclinical safety studies showed no findings...

Trial of ZW25 in Patients With Advanced HER2-expressing Cancers

Part 1 of the study will evaluate increasing doses of ZW25 to find the highest dose of ZW25 that does not cause unacceptable side effects (maximum-tolerated dose or MTD), the lowest safe dose with the highest rate of effectiveness (optimal biological dose or OBD), and/or other recommended dosages (RDs) of...

Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.

Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to undergoing any study procedures. Each treatment cycle is 28 calendar...

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show...

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R)...

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer...

Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Gemcitabine and Nab-paclitaxel) in Locally Advanced Pancreatic Cancer

Subjects will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with G/NP or placebo with G/NP. Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection to determine surgical outcome...

Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

- Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of cabozantinib when taken in combination with a standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks). - Expansion Stage: to determine the preliminary efficacy (objective response rate [ORR]...

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy...

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who...