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D010051: Ovarian Neoplasms

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (10)


Name (Synonyms) Correlation
drug2388 PF-07104091 monotherapy Wiki 0.58
drug1011 Deep Breathing training Wiki 0.58
drug876 Continuation of ACEi/ARB Wiki 0.58
Name (Synonyms) Correlation
drug859 Compassion focused intervention Wiki 0.58
drug3971 modification of the planned therapeutic management Wiki 0.58
drug2386 PF-07104091 + palbociclib Wiki 0.58
drug1072 Discontinuation of ACEi/ARB Wiki 0.58
drug2799 Radspherin Wiki 0.58
drug789 Choices and judgements Wiki 0.58
drug2387 PF-07104091 + palbociclib + letrozole Wiki 0.58

Correlated MeSH Terms (13)


Name (Synonyms) Correlation
D000077216 Carcinoma, Ovarian Epithelial NIH 0.58
D014594 Uterine Neoplasms NIH 0.58
D014625 Vaginal Neoplasms NIH 0.58
Name (Synonyms) Correlation
D014846 Vulvar Neoplasms NIH 0.58
D010534 Peritoneal Neoplasms NIH 0.58
D055752 Small Cell Lung Carcinoma NIH 0.41
D002583 Uterine Cervical Neoplasms NIH 0.41
D064726 Triple Negative Breast Neoplasms NIH 0.33
D002289 Carcinoma, Non-Small-Cell Lung NIH 0.26
D001943 Breast Neoplasms NIH 0.26
D002277 Carcinoma NIH 0.20
D008175 Lung Neoplasms NIH 0.18
D009369 Neoplasms, NIH 0.11

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0100615 Ovarian neoplasm HPO 0.82
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:0003002 Breast carcinoma HPO 0.26
HP:0030731 Carcinoma HPO 0.20
HP:0002664 Neoplasm HPO 0.11

Clinical Trials

Navigate: Correlations   HPO

There are 3 clinical trials


1 A Phase 1 Study to Evaluate the Dose, Safety and Tolerability of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis Following CRS

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).

NCT03732768
Conditions
  1. Peritoneal Carcinomatosis
  2. Ovarian Cancer
Interventions
  1. Drug: Radspherin
MeSH:Ovarian Neoplasms Carcinoma, Ovarian Epithelial Carcinoma Peritoneal Neoplasms
HPO:Carcinoma Ovarian neoplasm

Primary Outcomes

Description: To investigate safety and toxicity of Radspherin®

Measure: Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0.

Time: 12 months

Description: 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 days
2 Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

The 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.

NCT04351139
Conditions
  1. Gynecologic Cancer
  2. Breast Neoplasm Female
  3. Uterine Neoplasms
  4. Ovarian Neoplasms
  5. Uterine Cervical Neoplasms
  6. Vulvar Neoplasms
  7. Vaginal Neoplasms
Interventions
  1. Other: modification of the planned therapeutic management
MeSH:Neoplasms Breast Neoplasms Ovarian Ovarian Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Vulvar Neoplasms Vaginal Neoplasms
HPO:Breast carcinoma Cervical polyp Cervix cancer Neoplasm Neoplasm of the breast Ovarian neoplasm Uterine neoplasm Vaginal neoplasm Vulvar neoplasm

Primary Outcomes

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 O
3 PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

To 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.

NCT04553133
Conditions
  1. Small Cell Lung Cancer
  2. Ovarian Cancer
  3. Triple Negative Breast Cancer
  4. Non-small Cell Lung Cancer
  5. Human Receptor-positive Human Epidermal Growth Factor Receptor 2
Interventions
  1. Drug: PF-07104091 monotherapy
  2. Drug: PF-07104091 + palbociclib
  3. Drug: PF-07104091 + palbociclib + letrozole
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Small Cell Lung Carcinoma Triple Negative Breast Neoplasms
HPO:Neoplasm of the lung Non-small cell lung carcinoma Ovarian neoplasm Small cell lung carcinoma

Primary Outcomes

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 days

Description: 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)

Secondary Outcomes

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)

HPO Nodes


Reports

Data processed on September 26, 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  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook