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ABI-009 (Nab-Rapamycin) in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma

Study Purpose

A Phase 2, Open-label Study of ABI-009 (nab-Rapamycin) in Bevacizumab-Naïve Subjects with Progressive High Grade Glioma Following Prior Therapy and Subjects with Newly Diagnosed Glioblastoma. ABI-009 will be tested as single agent or in combination with standard therapies

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria Specific for Arms A 1. All subjects must have histologic evidence of high grade glioma (World Health Organization [WHO] grade 3 or grade 4) and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion, or a significant increase in T2 FLAIR). Subjects must have at least 1 measurable lesion by RANO criteria (≥ 10 mm in 2 perpendicular diameters). 2. Subjects must have previously completed standard radiation therapy and been exposed to temozolomide. 3. No prior treatment with mTOR inhibitors, or BEV or any other anti-angiogenic agents, including sorafenib, sunitinib, axitinib, pazopanib, or cilengitide (for the ABI-009 + BEV arm), or MRZ or any other proteasome inhibitors, including BTZ, CFZ, or IXZ (for the ABI-009 + MRZ arm). 4. At least 4 weeks from surgical resection and at least 12 weeks from the end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are approximately 8 weeks apart. Inclusion Criteria Specific for Arms B 1. Histologically confirmed newly diagnosed glioblastoma. 2. Subjects must have had surgery and have a measurable post-contrast lesion after surgery detected by MRI. No prior treatment with mTOR inhibitors, and no prior local or systemic therapy for GBM. Exclusion Criteria Common for Both Arms A and B A patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. Co-medication or concomitant therapy that may interfere with study results. 2. History of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months. 3. Pregnant or breast feeding. 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state. 5. Active gastrointestinal bleeding. 6. Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication. 7. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. 8. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. 9. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009. 10. Known other previous/current malignancy requiring treatment within ≤ 3 years except for limited disease treated with curative intent, such as in situ prostate cancer, intracapsular renal cancer, cervical carcinoma in situ, squamous or basal cell skin carcinoma, and superficial bladder carcinoma. 11. Any comorbid condition that restricts the use of study drug and confounds the ability to interpret data from the study as judged by the Investigator or Medical Monitor. 12. Known Human Immunodeficiency Virus (HIV), or active Hepatitis B or Hepatitis C.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03463265
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aadi, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

John Wayne Cancer Institute, Santa Monica, California

Status

Recruiting

Address

John Wayne Cancer Institute

Santa Monica, California, 90404

Site Contact

Hanh Nguyen

nguyenthuyh@jwci.org

310-829-8265

Hoag Memorial Hospital Presbyterian, Newport Beach, California

Status

Recruiting

Address

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Site Contact

Laura Heim

laura.heim@hoag.org

949-764-8190

St. Joseph Heritage Healthcare, Fullerton, California

Status

Recruiting

Address

St. Joseph Heritage Healthcare

Fullerton, California, 92835

Site Contact

Linda Gozar

Linda.Gozar@stjoe.org

714-992-3000 #4332