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Expanded Access for ABI-009 in Patients With Advanced PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817515
Expanded Access Status : Available
First Posted : January 25, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aadi, LLC

Brief Summary:
Expanded Access for an Intermediate-size Population for ABI-009 (Sirolimus Albumin-bound Nanoparticles for Injectable Suspension) in Patients with Advanced Perivascular Epithelioid Cell Tumors (PEComa) and Patients with a Malignancy with Relevant Genetic Mutations or mTOR Pathway Activation

Condition or disease Intervention/treatment
PEComa, Malignant TSC1 TSC2 mTOR Pathway Abberation Drug: ABI-009

Detailed Description:
Expanded Access for an Intermediate-size Population for ABI-009 (Sirolimus Albumin-bound Nanoparticles for Injectable Suspension) in Patients with Advanced Perivascular Epithelioid Cell Tumors (PEComa) and Patients with a Malignancy with Relevant Genetic Mutations or mTOR Pathway Activation

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access for an Intermediate-size Population for ABI-009 (Sirolimus Albumin-bound Nanoparticles for Injectable Suspension) in Patients With Advanced Perivascular Epithelioid Cell Tumors (PEComa) and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus


Intervention Details:
  • Drug: ABI-009
    Sirolimus Albumin-bound Nanoparticles
    Other Name: nab-sirolimus, nab-rapamycin, albumin-bound sirolimus, Sirolimus Albumin-bound Nanoparticles

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

A patient will be eligible for inclusion in this expanded access program only if all of the following criteria are met:

  1. a) Diagnosis of advanced (locally advanced and inoperable or metastatic) malignant PEComa confirmed by pathology and immunohistochemistry, whether or not previously exposed to an mTOR inhibitor, or b) diagnosis of any other malignancy with activation in any mTOR pathway component as identified by immunohistochemistry or an identified relevant rare genetic mutation in mTOR pathway genes, including but not limited to TSC1, TSC2, PIK3CA, PTEN, for which there are no FDA-approved treatments or no other comparable or satisfactory alternative therapies available whether or not they been previously exposed to a mTOR inhibitor.
  2. 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  3. Acceptable blood chemistry levels at screening (obtained ≤14 days prior to enrollment (local laboratory) including:

    1. total bilirubin ≤1.5 x upper limit of normal (ULN)
    2. AST ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)
    3. serum creatinine ≤1.5 x ULN
  4. Adequate biological parameters as demonstrated by the following blood counts at screening (obtained ≤14 days prior to enrollment, local laboratory):

    1. Absolute neutrophil count (ANC) ≥1.5 × 109/L;
    2. Platelet count ≥100,000/mm3 (100 × 109/L);
    3. Hemoglobin ≥8 g/dL.
  5. Fasting serum triglyceride <300 mg/dL; fasting serum total cholesterol <350 mg/dL.
  6. Male or non-pregnant and non-breast feeding female:

    • Females of child-bearing potential must agree to use effective contraception without interruption from 28 days prior to starting IP and while on investigational medication and have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the expanded access protocol, and after the end of treatment. A second form of birth control is required even if she has had a tubal ligation.
    • Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the expanded access protocol. A second form of birth control is required even if he has undergone a successful vasectomy.
  7. Ability to understand and sign informed consent.

Exclusion Criteria:

A patient will not be eligible for inclusion in this protocol if any of the following criteria apply:

  1. Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥1 year.
  2. In the treating physician's opinion, the potential risks outweigh the potential benefits of therapy with ABI-009.
  3. Prior exposure to ABI-009.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817515


Contacts
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Contact: Berta Grigorian 8184168378 bgrigorian@aadibio.com

Sponsors and Collaborators
Aadi, LLC
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Responsible Party: Aadi, LLC
ClinicalTrials.gov Identifier: NCT03817515    
Other Study ID Numbers: PEX-002
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Perivascular Epithelioid Cell Neoplasms
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs