Study of ABI-009 in patients with advanced malignant perivascular epithelioid cell tumors (PEComa)

Study of ABI-009 in patients with advanced malignant perivascular epithelioid cell tumors (PEComa)

This phase 2 study will enroll approximately 30 patients with advanced (metastatic or locally advanced) malignant PEComa, who have not been previously treated with an mTOR inhibitor.

ABI-009 is a drug created using nanotechnology that binds rapamycin to a protein called human albumin. Rapamycin is classified as an “mTOR inhibitor” and blocks the activity of a protein called mTOR, which is known to be overactive in PEComa cancer cells. Rapamycin and similar types of therapeutics have been used in various other tumors, including advanced PEComas, but are not approved by the FDA for the treatment of PEComa. It is possible that the human albumin component of ABI-009 may allow rapamycin to reach cancer cells more effectively than rapamycin by itself.

Therefore, the purpose of this study is to determine whether ABI-009 will help effectively help shrink or delay the growth of your cancer.

Patients who have been diagnosed with advanced malignant perivascular epithelioid cell tumors or PEComa, and have not been treated with prior mTOR therapy can participate in this clinical trial. If you’re not sure if your diagnosis qualifies you to participate in this study, talk to your doctor. – For More Information

Clinical trials.gov: https://clinicaltrials.gov/ct2/show/NCT02494570

 

Study Name: A Phase 2 Study of ABI-009 in Patients With Advanced Malignant PEComa

A phase 2 multi-center investigation of efficacy of ABI-009 (nabrapamycin) in patients with advanced malignant perivascular epithelioid cell tumors (PEComa)

 

CT.GOV IDENTIFIER

NCT02494570

 

Study Centers

If you have questions about the study, please contact Heather Polley at (484) 467-9591 or hpolley@novellaclinical.com

Participating Site Locations (US ONLY):
BOSTON, MA ANN ARBOR, MI
NEW YORK, NY DURHAM, NC
STANFORD, CA ST LOUIS, MO
SANTA MONICA, CA SEATTLE, WA
HOUSTON, TX

 

Study Overview:

This phase 2 study will enroll approximately 30 patients with advanced (metastatic or locally advanced) malignant PEComa, who have not been previously treated with an mTOR inhibitor.

ABI-009 is a drug created using nanotechnology that binds rapamycin to a protein called human albumin. Rapamycin is classified as an “mTOR inhibitor” and blocks the activity of a protein called mTOR, which is known to be overactive in PEComa cancer cells. Rapamycin and similar types of therapeutics have been used in various other tumors, including advanced PEComas, but are not approved by the FDA for the treatment of PEComa. It is possible that the human albumin component of ABI-009 may allow rapamycin to reach cancer cells more effectively than rapamycin by itself.

Therefore, the purpose of this study is to determine whether ABI-009 will help effectively help shrink or delay the growth of your cancer.

Patients who have been diagnosed with advanced malignant perivascular epithelioid cell tumors or PEComa, and have not been treated with prior mTOR therapy can participate in this clinical trial. If you’re not sure if your diagnosis qualifies you to participate in this study, talk to your doctor.

 

Key Inclusion Criteria- Patients Must:
  • Patients must have a histologically confirmed diagnosis of malignant PEComa

that is either metastatic or locally advanced and for which surgery is not a

recommended option

  • Patients must have available tumor block along with the corresponding pathology

report and/or fresh biopsy to allow retrospective centralized confirmation of malignant

PEComa

  • Patients must have one or more measurable target lesions by CT scan or MRI,

Measurable disease by RECIST v1.1

  • Have good liver and kidney organ function on blood tests

 

Please note that there are other eligibility requirements that the study doctor will discuss with you if you are interested in participating in this study.

 

Key Exclusion Criteria- Patients Must NOT:
  • Have been previously treated with an mTOR inhibitor
  • Have lymphangioleiomyomatosis (LAM)
  • Have spread of their tumor (sarcoma) to the brain which is causing symptoms or making the patient’s overall health unstable.   If tumor has involved the brain but is stable then patients may be considered for the study
  • Be pregnant or breast feeding

 

Please note that there are other eligibility requirements that the study doctor will discuss with you if you are interested in participating in this study.

 

REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT
  • The study team will need to get a sample of your tumor taken from a previous surgery or biopsy
  • Blood tests to measure your complete blood count, liver function, and fasting lipids
  • A heart rhythm tracing (ECG)
  • A CT or MRI scan to measure your tumor if not done within 28 days of starting the study therapy

 

  • POTENTIAL SIDE-EFFECTS

    The most common side effects observed in > 10 % of patients have been: anemia neutropenia, constipation, nausea, diarrhea, fatigue, elevation of liver tests, rash, infection, weight loss, and shortness of breath

 

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