nab-sirolimus for Neoplasm Metastasis

Phase-Based Estimates
1
Effectiveness
2
Safety
New Jersey Cancer Care and Blood Disorders, Belleville, NJ
+18 More
nab-sirolimus - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Neoplasm Metastasis

Study Summary

This study is evaluating whether a drug called ABI-009 can help treat a type of cancer called tuberous sclerosis complex.

See full description

Eligible Conditions

  • Neoplasm Metastasis
  • Cancer
  • Metastasis
  • Neoplasms, Metastatic
  • Cancer, Advanced
  • Malignancies
  • Neoplasms, Malignant
  • TSC
  • TSC1
  • Solid Metastatic Tumor
  • Solid Malignant Tumors
  • Malignant Solid Neoplasms
  • TSC2
  • Tumors
  • Metastatic Cancers
  • Solid Tumors, Advanced Solid Tumors
  • Neoplasms
  • Tumors, Solid
  • Solid Tumors, Adult
  • Solid Tumor, Childhood

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether nab-sirolimus will improve 1 primary outcome and 7 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of 9 months.

24 months
Overall survival
9 months
Disease control rate
Duration of response (DOR)
Incidence and severity of treatment-emergent and treatment-related adverse events (AEs)
Overall response rate (ORR)
Patient-reported outcome
Progression-free survival
Time to response

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

No Control Group
Arm C: Pathogenic inactivating TSC1 or TSC2 alterations

This trial requires 120 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nab-sirolimus is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm C: Pathogenic inactivating TSC1 or TSC2 alterations
Drug
Arm A: Pathogenic inactivating TSC1 alterations
Drug
Arm B: Pathogenic inactivating TSC2 alterations
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

New Jersey Cancer Care and Blood Disorders - Belleville, NJ

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have a malignant solid tumor with a pathogenic inactivating TSC1 or TSC2 alteration show original
• Patients will be enrolled after the central evaluation of NGS report confirms eligibility. show original
Patients must provide baseline tumor tissue samples.
You have solid tumors that are metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity. show original
Patients must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the patient has no satisfactory alternative treatments.
Patients must have 1 or more measurable target lesions by CT scan or MRI (RECIST v1.1) at baseline. show original
You must be 12 years or older to participate in this study. show original
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) ≥80 or Lansky play-performance scale for pediatric patients ≥80
You have a total bilirubin level of ≤1.5 × ULN or ≤3 × ULN. show original
Aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)

Patient Q&A Section

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

What are the common side effects of nab-sirolimus?

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The side effects of nab-SRL correlate directly with age. The most common side effects are fever, rash, and abdominal pain. Serious complications, such as renal impairment (proteinuria) or pneumonitis (dry cough, dyspnea, chest pain) could be reversible by drug dose reduction or withdrawal of SRL or other immunosuppressants, and supportive care.

Unverified Answer

What are the signs of cancer?

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Signs that may occur in a person with cancer include: unintentional weight loss, loss of appetite, vomiting or constipation, swelling of any one part of the body, change in stool frequency or colour, or bleeding or bruising more often or for longer-than-normal time.\n

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Can cancer be cured?

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The evidence supporting the idea that cancer may be curable is scarce, although early stage breast and colon cancer seem to be better treated than advanced cancer. There does not appear to be any evidence that cancer can be cured, although for some cancers there is evidence of potential cure.

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What are common treatments for cancer?

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The treatment of cancer in real life is less than ideal. Although advances in the medical treatment of cancer have improved survival rates, many patients with cancer are still not given the opportunity to benefit from innovative new drugs.

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How many people get cancer a year in the United States?

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Cancer accounts for 17% of all illness and 23% of deaths. About one in seven men or 1 in 8 women suffer cancer annually. The highest prevalence of cancer among blacks is seen in the prostate, bronchus, stomach, and esophageal cancer. The highest mortality is seen in cancer of the colon, prostate, lung, and stomach. The high prevalence of lung cancer and stomach cancer seems to be a reflection of cigarette smoking. The high mortality seen with colon cancer could reflect the impact on colorectal cancer of diet, genetics, and other, as yet obscure, factors.

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What is cancer?

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Cancer is a group of diseases involving an uncontrolled proliferation of abnormal cells. This can occur from a variety of genetic or environmental factors and may be divided into three separate phases of disease: benign neoplasia, malignant neoplasia, and metastasisation. There are some cancers in which one or more of these phases are more predominant.

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What causes cancer?

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It is widely accepted that cancer has inherent genetic and environmental causes. Although genetic factors are clearly relevant to human cancer, they were generally not considered in early studies of cancer risk factors, especially lung cancer. These more recent studies have revealed significant associations between risk factors, such as cigarette smoking, and cancer risk. As such, these studies suggest that there can be some shared risk factors for cancer that operate at various timepoints in the sequence of causality.

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Is nab-sirolimus safe for people?

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In conclusion, sirolimus was safe and active in this cohort of people with advanced cancer. These retrospective findings support earlier results in a large, prospective trial. Furthermore, our findings in this population support the use of these agents as a third line therapy.

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What is the average age someone gets cancer?

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In the United States and Canada, the average age on diagnosis for non-metastatic [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is 58 years. In the Netherlands, it is 63 years (2005, latest report to date). Because the prevalence of breast cancer increases with age, this raises the question whether there is a threshold for screening age.\n\n- Cancer\n- Metastasis\n- List of cancers\n- Palliative medicine\n- Hospice\n- End of life care\n- Terminal illness"

"A. D. M.

Unverified Answer

What are the latest developments in nab-sirolimus for therapeutic use?

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Recent developments in targeted therapy with mTOR inhibitors are proving to be of great utility in the treatment of the pediatric patients with high-risk and high-grade B-ALL, particularly with regards to avoiding the development of overt myelosuppression.

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Who should consider clinical trials for cancer?

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There are many patients who do not wish to participate in clinical trials. Most do not know about the benefits and risks, and few feel they would benefit from participating, especially if they have high quality life or if they are on effective treatment with proven efficacy. A minority of patients will not attend a session of a study if they are told about the risks, or attend a trial. The patient needs to be informed that his/her treatment may be improved, but that the trial is part of the patient's treatment, and that the trial participants will be the same people as everyone else in the trial. Patients should know that their treatment may be improved, but that the patient's treatment is part of the protocol.

Unverified Answer

What does nab-sirolimus usually treat?

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It certainly can be used for refractory or relapsed MM at first presentation and the combination with other agents. I do believe however, that it is important for patients with PFS who are in stable and excellent CR after all chemotherapy regimes and other agents to receive a trial of SRL alone or SRL in combination to help see if it will do any good as a longer-term maintenance therapy. At the age of 60–64 years, I believe patients should have at least 1 year of surveillance, if we would like to avoid the risk of having a secondary or tertiary malignancy in later life.

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