Clinical Trials /

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

NCT03463265

Description:

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

Related Conditions:
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Glioblastoma
  • Malignant Glioma
  • WHO Grade III Glioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: GBM007
  • NCT ID: NCT03463265

Conditions

  • High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma

Interventions

DrugSynonymsArms
ABI-009nab-rapamycin, nanoparticle albumin-bound rapamycinABI-009
BevacizumabABI-009 + bevacizumab
TemozolomideABI-009 + temozolamide
LomustineABI-009 + lomustine

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

Trial Arms

NameTypeDescriptionInterventions
ABI-009Experimental
  • ABI-009
ABI-009 + bevacizumabExperimental
  • ABI-009
  • Bevacizumab
ABI-009 + temozolamideExperimental
  • ABI-009
  • Temozolomide
ABI-009 + lomustineExperimental
  • ABI-009
  • Lomustine
ABI-009 + temozolamide + radiotherapyExperimental
  • ABI-009
  • Temozolomide

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:objective overall response rate according to RANO 2010 criteria
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:12 months
Safety Issue:
Description:
Measure:progression free survival
Time Frame:12 months
Safety Issue:
Description:
Measure:overall survival
Time Frame:12 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aadi, LLC

Last Updated