IPI-549 (eganelisib) for Triple Negative Breast Neoplasms
This study is evaluating whether a drug called IPI-549 can be used to treat cancer.
See full descriptionAbout the trial for Triple Negative Breast Neoplasms
Treatment Groups
This trial involves 11 different treatments. IPI-549 (eganelisib) is the primary treatment being studied. Participants will be divided into 11 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether IPI-549 (eganelisib) will improve 2 primary outcomes and 28 secondary outcomes in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment from date of initial dose until 30 days after last dose of IPI-549 and 100 days after the last dose of Nivolumab.
Patient Q & A Section
Has ipi-549 (eganelisib) proven to be more effective than a placebo?
In this trial of advanced sarcoma, response rates and PFS were higher in the eganelisib group than in the placebo group. Eganelisib was granted accelerated approval by the U.S. Food and Drug Administration.
What causes carcinoma, non-small-cell lung?
Lung carcinomas have many characteristics in common, including histological subtypes, behavior, and outcomes, which indicates that [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) may be caused and/or driven by the same cellular processes and/or signals that are involved with the development and progression of other cancers. These data indicate that carcinoma, non-small cell lung, may be caused or propelled by processes in tumors of the breast, colon, and prostate.
How many people get carcinoma, non-small-cell lung a year in the United States?
Carcinoma, non-small-cell lung was the second-most frequent cancer reported to SEER, with an estimated 2,539 new cases per year in the United States. The number of new cases each year in this series was estimated to be the same as that estimated for carcinoma, non-small cell lung for 2004 and 2005.
Can carcinoma, non-small-cell lung be cured?
Results from a recent paper we found that treatment with vincristine and cyclophosphamide resulted in a high probability of remission, and a good overall survival (average 44 months) of 12 months. The number of patients in this group was small precluded a statistically significant analysis. The main reason for the relatively poor performance of first-line chemotherapy is the low probability to obtain a complete response after the first line.
What is carcinoma, non-small-cell lung?
Lung cancer is the most common form of lung cancer. It manifests a wide range of symptoms both at presentation and as it progresses. There are at least three major groups of pulmonary lesions at presentation: small lung cancer, extrapulmonary metastases, and massive hematogenous spread. In the early stages, treatment may relieve symptoms. In the more advanced stages chemotherapy and targeted therapies should be considered.
What are the signs of carcinoma, non-small-cell lung?
The main signs are cough on exercise and weight loss from malignancy, as well as hemoptysis. Other signs such as pleural effusion on auscultation have a high sensitivity.
What are common treatments for carcinoma, non-small-cell lung?
About half of patients will have systemic treatment. Radiation remains a commonly used form of treatment for most NSCLC subtypes. The role of chemotherapy and targeted agents, for both early and advanced stages of NSCLC remains controversial. There is no significant long-term survival advantage obtained by chemotherapy for early-stage NSCLC. However, chemotherapy is usually curative for patients with advanced NSCLC.
Is ipi-549 (eganelisib) typically used in combination with any other treatments?
In the first phase III trial of eganelisib alone and with chemotherapy or paclitaxel for treatment of advanced squamous non-small cell lung cancer, eganelisib was considered to be a promising single agent. In the pooled analysis of the two trials, eganelisib was shown to be highly active. It should be considered as a therapy for patients with advanced squamous cell lung cancers and a promising novel treatment for patients with high-risk non-small-cell lung cancer.
What are the common side effects of ipi-549 (eganelisib)?
The most common side effects in this prospective, Phase I, single-arm study were fatigue (75% of patients), loss of appetite (67%), headaches (61%), nausea (55%), and diarrhea (54%); other common side effects were upper respiratory tract infection (41%), fatigue (37%), and fever (35%) and chills (32%).
What is ipi-549 (eganelisib)?
The most common side effects are diarrhea and pain. They are manageable. Eganelisib may cause or worsen cancer symptoms. It is important to know when you are first on the drug and how your nosebleed risk changes. You need to keep a record of the adverse effects you have had while on the study drugs, what the effects were and what level of the study drugs you had on your body. You also need to know what the side effects of your cancer medication are. If you are taking other drugs, you need to keep a record of your dose so your physician and study investigator can tell you if you are in the right dose range.
Who should consider clinical trials for carcinoma, non-small-cell lung?
The performance status and tumor stage may be the most important factors to exclude patients from enrollment in a clinical trial. Further investigation of the inclusion criteria and appropriate selection of patients to clinical trials for carcinoma, non-small-cell lung is mandatory.
How quickly does carcinoma, non-small-cell lung spread?
In addition to the conventional staging methods, it is more rational to use the clinical course of patients after complete surgical removal of the chest wall. That way, the extent of chest wall involvement is more accurately assessed.