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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1002 | Clinical Observation Wiki | 0.58 |
| drug3568 | Radspherin Wiki | 0.58 |
| drug5060 | modification of the planned therapeutic management Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3038 | PF-07104091 + palbociclib + letrozole Wiki | 0.58 |
| drug3428 | Prototype swab Wiki | 0.58 |
| drug4557 | Ultra Brief Online Mindfulness-based Intervention Wiki | 0.58 |
| drug1130 | Control swab Wiki | 0.58 |
| drug3039 | PF-07104091 monotherapy Wiki | 0.58 |
| drug3037 | PF-07104091 + palbociclib Wiki | 0.58 |
| drug1116 | Control Wiki | 0.15 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D010534 | Peritoneal Neoplasms NIH | 0.58 |
| D000077216 | Carcinoma, Ovarian Epithelial NIH | 0.58 |
| D014594 | Uterine Neoplasms NIH | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014625 | Vaginal Neoplasms NIH | 0.58 |
| D014846 | Vulvar Neoplasms NIH | 0.58 |
| D002583 | Uterine Cervical Neoplasms NIH | 0.41 |
| D055752 | Small Cell Lung Carcinoma NIH | 0.33 |
| D064726 | Triple Negative Breast Neoplasms NIH | 0.26 |
| D002289 | Carcinoma, Non-Small-Cell Lung NIH | 0.24 |
| D001943 | Breast Neoplasms NIH | 0.22 |
| D002277 | Carcinoma NIH | 0.17 |
| D008175 | Lung Neoplasms NIH | 0.14 |
| D009369 | Neoplasms, NIH | 0.08 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100615 | Ovarian neoplasm HPO | 1.00 |
| HP:0100650 | Vaginal neoplasm HPO | 0.58 |
| HP:0030416 | Vulvar neoplasm HPO | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0010784 | Uterine neoplasm HPO | 0.58 |
| HP:0030079 | Cervix cancer HPO | 0.41 |
| HP:0030357 | Small cell lung carcinoma HPO | 0.33 |
| HP:0030358 | Non-small cell lung carcinoma HPO | 0.24 |
| HP:0003002 | Breast carcinoma HPO | 0.22 |
| HP:0030731 | Carcinoma HPO | 0.17 |
| HP:0100526 | Neoplasm of the lung HPO | 0.14 |
| HP:0002664 | Neoplasm HPO | 0.08 |
Navigate: Correlations HPO
There are 3 clinical trials
RAD-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 daysThe current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.
Description: modification of the planned therapeutic management
Measure: percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy) Time: Day OTo assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.
Description: Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Measure: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle Time: 28 daysDescription: Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
Measure: To evaluate incidence of treatment emergent adverse events and laboratory abnormalities Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
Measure: Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
Measure: Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
Measure: To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline Time: From baseline until end of study treatment or study completion (approximately 2 years)Description: Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
Measure: To evaluate the preliminary antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose expansion Time: From baseline through disease progression or study completion (approximately 2 years)Description: Peak concentration of PF-07104091 during selected cycles
Measure: Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: Time to peak concentration of PF-07104091 during selected cycles
Measure: Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: AUC of PF-07104091 will be calculated at selected cycles
Measure: Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091 Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)Description: AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
Measure: Area under the curve of PF-07104091 with or without food Time: From baseline through time to event on study or study completion (approximately 2 years)Description: Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
Measure: Maximum plasma concentration of PF-07104091 with or without food Time: From baseline through time to event on study or study completion (approximately 2 years)Description: Percentage of participants with a best overall response of CR or PR using RECIST 1.1
Measure: To document any preliminary evidence of antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose escalation Time: From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)Description: Time from first assessment of event endpoint to last assessment of using RECIST 1.1
Measure: To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints Time: From baseline through time to event on study or study completion (approximately 2 years)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports