Name (Synonyms) | Correlation | |
---|---|---|
drug614 | Carboplatin Wiki | 0.63 |
drug753 | Convalescent Plasma (CP) Wiki | 0.63 |
drug931 | Drugs and supportive care Wiki | 0.45 |
drug2363 | Radspherin Wiki | 0.45 |
drug392 | Berzosertib Wiki | 0.45 |
drug36 | 30 Gy over 3 weeks Wiki | 0.45 |
drug1065 | F-FMISO PET/CT Scan Wiki | 0.45 |
drug2676 | Standard COVID-19 therapies Wiki | 0.45 |
drug909 | Docetaxel Wiki | 0.45 |
drug3362 | nasopharyngeal Covid 19 RT-PCR Wiki | 0.45 |
drug51 | 5Fluorouracil Wiki | 0.45 |
drug673 | Cisplatin Wiki | 0.45 |
drug1546 | Laboratory Biomarker Analysis Wiki | 0.45 |
drug2262 | Proton Therapy Wiki | 0.45 |
drug752 | Convalescent Plasma Wiki | 0.27 |
drug344 | BI 894999 Wiki | 0.26 |
drug2122 | Placebo Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D002277 | Carcinoma NIH | 1.00 |
D002294 | Carcinoma, Squamous Cell NIH | 0.45 |
D000077216 | Carcinoma, Ovarian Epithelial NIH | 0.45 |
D010534 | Peritoneal Neoplasms NIH | 0.45 |
D006528 | Carcinoma, Hepatocellular NIH | 0.45 |
D010051 | Ovarian Neoplasms NIH | 0.32 |
D011471 | Prostatic Neoplasms NIH | 0.22 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002860 | Squamous cell carcinoma HPO | 0.45 |
HP:0001402 | Hepatocellular carcinoma HPO | 0.45 |
HP:0100615 | Ovarian neoplasm HPO | 0.32 |
HP:0012125 | Prostate cancer HPO | 0.22 |
There are 5 clinical trials
The aim of the phase Ia (dose escalation) part of this trial is to assess-> determine the Maximum Tolerated Dose (MTD) using a continuous dosing schedule A, using an intermittent Schedule B (2 weeks on, one week off in 3-week cycles) and the MTD using an intermittent Schedule C (one week on followed by one week off treatment, repeated every two weeks in 4-week cycles) in patients with solid tumours. In the phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the dose recommended by the data monitoring committee (DMC). Once the MTD has been determined for both schedules A and B in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the DMC recommended schedule for solid tumours
The purpose of this study is to demonstrate that participants with HPV positive and hypoxia negative T1-2, N1-2c (AJCC, 7th ed.) oropharyngeal squamous cell carcinoma receiving a major de-escalated radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable subjects treated with the current standard chemoradiation. Given the restrictions of surgery during the COVID19 pandemic, we will start enrolling patients on Cohort B where surgery is not required. Once the COVI19 pandemic is over, we will resume and complete enrollment on Cohort A where surgery is required, prior to continuing enrolling patients on Cohort B. During the COVID-19 pandemic, the research MRIs are optional.
This phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.
Description: Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen [PSA] response of > 50%). Will be conducted using the Cochran-Mantel-Haenszel test, with one-sided p-value of =< 0.05 considered significant.
Measure: Response rate (complete response + partial response) Time: Up to 2 yearsDescription: Assessed by Prostate Cancer Working Group (PCWG)3. PFS to be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Progression-free survival (PFS) Time: From the time of randomization up to 2 yearsDescription: Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval. Comparison of time to PSA progression between arms will be conducted using the log-rank test.
Measure: Time to PSA progression Time: From the time of randomization up to 2 yearsDescription: Assessed by RECIST 1.1. rPFS will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Radiographic progression-free survival (rPFS) Time: From the time of randomization up to 2 yearsDescription: Will be summarized according to treatment arm. For toxicity reporting, all adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Type of adverse events, intensity (grading), and attribution will be provided in a listing. All adverse events resulting in discontinuation, dose modification, and/or dosing interruption, and/or treatment delay of drug will also be summarized. Laboratory test results will be classified according to the CTCAE version 5.0.
Measure: Incidence of adverse events Time: Up to 2 yearsDescription: OS will be estimated with the Kaplan Meier methodology. Comparison of OS between arms will be conducted using the log-rank test base on the intention-to-treat approach, where two treatment arms will be compared regardless of cross-over or any subsequent therapy.
Measure: Overall survival (OS) Time: From the time of randomization up to 2 yearsDescription: Gene mutation frequencies and mean +/- standard deviation of quantitative biomarkers will be summarized by arm and in overall population at baseline and/or at end of study.
Measure: Gene mutation frequencies Time: Baseline up to 2 yearsRAD-18-001 is a First-In-Man, Dose Escaltion study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Acceptability of up to 7 MBq gives the opportunity to explore the doses of the dose escalation split into two administrations, and given as two separate injections 1 week apart. Split doses of 1, 2 and 3.5 MBq will be administered as two injections. Each subject will be followed until disease progression (in the abdominal cavity), or for 12 months after the administration of Radspherin® (whichever comes first).
Description: To investigate safety and toxicity of Radspherin®
Measure: Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0. Time: 12 monthsDescription: To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)
Measure: Maximum Tolerated Dose (MTD) Time: 21 daysSince December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic
Description: Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
Measure: Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France Time: 6 months