CLINICAL TRIAL

IPI-549 (eganelisib) for Triple Negative Breast Neoplasms

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Santa Monica, CA

This study is evaluating whether a drug called IPI-549 can be used to treat cancer.

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About the trial for Triple Negative Breast Neoplasms

Eligible Conditions
Triple Negative Breast Neoplasms · Head and Neck Neoplasms · High-circulating Myeloid-derived Suppressor Cells (Part H) · Melanoma (Part E) · Neoplasms, Squamous Cell · Carcinoma, Non-Small-Cell Lung · Mesothelioma · Squamous Cell Cancer of the Head and Neck (Part E) · Adrenocortical Carcinoma · Carcinoma, Squamous Cell · Non-small Cell Lung Cancer (Part E) · Melanoma · Mesothelioma, Malignant · Adrenocortical Carcinoma (Part G) · Mesothelioma (Part G) · Triple Negative Breast Cancer (Part F) · Advanced Solid Tumors (Part A/B/C/D)

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.

Experimental Group 1
IPI-549 (eganelisib)
DRUG
+
Nivolumab
DRUG
Experimental Group 2
IPI-549 (eganelisib)
DRUG
+
Nivolumab
DRUG
Experimental Group 3
IPI-549 (eganelisib)
DRUG
+
Nivolumab
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient did not respond to standard therapy, or there was no appropriate therapy available. show original
The text is about evidence of advanced cancer show original
A person has a serum creatinine clearance of ≥ 60 mL/min and a serum creatinine of ≤ 2.0 x the upper limit of normal (ULN) if their estimated creatinine clearance is calculated by the Cockcroft-Gault equation to be ≥ 60 mL/min or their creatinine clearance is determined by a 24-hour urine collection to be ≥ 60 mL/min. show original
Individuals with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 (corresponds to a Karnofsky Performance Status of ≥ 60%) are generally considered to be in good health and have a low risk of death. show original
The total bilirubin level should be ≤ 1.5 x the upper limit of the normal range (ULN), unless it is elevated due to Gilbert's syndrome. show original
AST/SGOT and ALT/SGPT should be no more than 2.5 times the upper limit of the normal range (ULN) for adults show original
, is required for initiation of therapy with B-cell lymphoma In order to start treatment for B-cell lymphoma, a person's hematological function must be adequate, meaning their absolute neutrophil count is at least 1.5 x 109/L, their hemoglobin is at least 9.0 g/dL, and their platelet count is at least 100 x 109/L. show original
You must be at least 18 years of age to purchase this product. show original
The life expectancy of a person with a progressive, life-limiting illness is ≥ 3 months. show original
must be present At least one measurable disease lesion must be present. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Part D/E: Adverse Events (AE) and safety laboratory values
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
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
Part G: Plasma concentrations of IPI-549 (and metabolites, as appropriate)
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
Part E: Plasma concentrations of IPI-549 (and metabolites, as appropriate)
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
Part C: Plasma concentrations of IPI-549 (metabolites as appropriate)
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
Part F: Plasma concentrations of IPI-549 (and metabolites, as appropriate)
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
ASSESSED DURING DAYS 1- 2 OF CYCLES 1 AND 2
Part A/B/C: Dose Limiting Toxicities (DLT)
FROM DATE OF INITIAL DOSE UNTIL UP TO 28 DAYS FOR IPI-549
FROM DATE OF INITIAL DOSE UNTIL UP TO 28 DAYS FOR IPI-549
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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%).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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