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

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ClinicalTrials.gov Identifier: NCT03463265
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Aadi, LLC

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2018)
objective overall response rate according to RANO 2010 criteria [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03463265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]
  • progression free survival [ Time Frame: 12 months ]
  • overall survival [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2018)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]
  • duration of response [ Time Frame: 12 months ]
  • progression free survival [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABI-009 (Nab-Rapamycin) in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma
Intervention  ICMJE
  • 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
  • Drug: Temozolomide
    temozolamide
  • Drug: Lomustine
    lomustine
  • Radiation: radiation
    radiation
Study Arms  ICMJE
  • Experimental: ABI-009
    Intervention: Drug: ABI-009
  • Experimental: ABI-009 + bevacizumab
    Interventions:
    • Drug: ABI-009
    • Drug: Bevacizumab
  • Experimental: ABI-009 + temozolamide
    Interventions:
    • Drug: ABI-009
    • Drug: Temozolomide
  • Experimental: ABI-009 + lomustine
    Interventions:
    • Drug: ABI-009
    • Drug: Lomustine
  • Experimental: ABI-009 + temozolamide + radiotherapy
    Interventions:
    • Drug: ABI-009
    • Drug: Temozolomide
    • Radiation: radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2018)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Berta Grigorian 818-416-8378 bgrigorian@aadibio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03463265
Other Study ID Numbers  ICMJE GBM007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aadi, LLC
Study Sponsor  ICMJE Aadi, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aadi, LLC
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP