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

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: NCT03463265
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aadi, LLC

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma Drug: ABI-009 Drug: Bevacizumab Drug: Temozolomide Drug: Lomustine Radiation: radiation Drug: Marizomib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABI-009 Drug: ABI-009
ABI-009 as single agent or in combination with other agents
Other Name: nab-rapamycin, nanoparticle albumin-bound rapamycin
Experimental: ABI-009 + bevacizumab Drug: ABI-009
ABI-009 as single agent or in combination with other agents
Other Name: nab-rapamycin, nanoparticle albumin-bound rapamycin

Drug: Bevacizumab
bevacizumab
Experimental: ABI-009 + temozolamide Drug: ABI-009
ABI-009 as single agent or in combination with other agents
Other Name: nab-rapamycin, nanoparticle albumin-bound rapamycin

Drug: Temozolomide
temozolamide
Experimental: ABI-009 + lomustine Drug: ABI-009
ABI-009 as single agent or in combination with other agents
Other Name: nab-rapamycin, nanoparticle albumin-bound rapamycin

Drug: Lomustine
lomustine
Experimental: ABI-009 + temozolamide + radiotherapy Drug: ABI-009
ABI-009 as single agent or in combination with other agents
Other Name: nab-rapamycin, nanoparticle albumin-bound rapamycin

Drug: Temozolomide
temozolamide

Radiation: radiation
radiation
Experimental: ABI-009 + marizomib Drug: ABI-009
ABI-009 as single agent or in combination with other agents
Other Name: nab-rapamycin, nanoparticle albumin-bound rapamycin

Drug: Marizomib
marizomib


Outcome Measures
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Primary Outcome Measures :
  1. objective overall response rate according to RANO 2010 criteria [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]
  2. progression free survival [ Time Frame: 12 months ]
  3. overall survival [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT03463265


Contacts
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Contact: Berta Grigorian 818-416-8378 bgrigorian@aadibio.com

Locations
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United States, California
St. Joseph Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
Contact: Linda Gozar    714-992-3000 ext 4332    Linda.Gozar@stjoe.org   
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Laura Heim    949-764-8190    laura.heim@hoag.org   
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Hanh Nguyen    310-829-8265    nguyenthuyh@jwci.org   
Sponsors and Collaborators
Aadi, LLC
More Information
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Responsible Party: Aadi, LLC
ClinicalTrials.gov Identifier: NCT03463265    
Other Study ID Numbers: GBM007
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Sirolimus
Bevacizumab
Temozolomide
Lomustine
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors