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ANG1005 in Patients With Recurrent High-Grade Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01967810
First received: October 9, 2013
Last updated: January 4, 2016
Last verified: January 2016

October 9, 2013
January 4, 2016
October 2013
June 2016   (final data collection date for primary outcome measure)
  • Objective Response Rate (ORR) (Arms 1 and 3) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma WHO Grade III patients (Arm 3)
  • PFS3 (Arm 2) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)
Same as current
Complete list of historical versions of study NCT01967810 on ClinicalTrials.gov Archive Site
  • ORR in Arm 2 [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    To determine the ORR in Arm 2
  • PFS at 3, 6 and 12 months [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    • To determine the number of patients without progression at 3, 6 and 12 months in Arms 1 and 3
    • To determine the number of patients without progression at 6 and 12 months in Arm 2
  • Median PFS [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    To determine the median progression-free survival in each arm
  • Duration of response [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
    To determine the median duration of response in each arm
  • Overall survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: Yes ]
    To determine the median overall survival in each arm
  • Safety and tolerability [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: Yes ]
    To determine the number of participants with adverse events
  • Pharmacokinetics [ Time Frame: At 0 h (pre-dose), at the end of infusion, at 2 and 4 hours post-dose on Day 1 of treatment cycles 1 and 3 (Week 1 and Week 9) ] [ Designated as safety issue: No ]
    To determine the drug concentration and distribution in the blood (plasma)
Same as current
Not Provided
Not Provided
 
ANG1005 in Patients With Recurrent High-Grade Glioma
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
See above.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glioma
  • Glioblastoma
  • Brain Tumor, Recurrent
  • Drug: ANG1005
    ANG1005 at a starting dose of 650 mg/m2 by intravenous infusion once every 3 weeks
    Other Name: GRN1005
  • Drug: Bevacizumab
    For patients enrolled in the bevacizumab-refractory in recurrent GBM (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
    Other Name: Avastin
  • Experimental: Arm 1
    ANG1005 administered to bevacizumab-naive recurrent GBM patients
    Intervention: Drug: ANG1005
  • Experimental: Arm 2
    ANG1005 and possibly bevacizumab administered to bevacizumab-refractory recurrent GBM patients
    Interventions:
    • Drug: ANG1005
    • Drug: Bevacizumab
  • Experimental: Arm 3
    ANG1005 administered to recurrent WHO Grade III anaplastic glioma
    Intervention: Drug: ANG1005
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
83
July 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. ≥ 18 years old
  2. GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed
  3. Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
  4. Neurologically stable
  5. For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy
  6. Karnofsky performance status (KPS) ≥ 70

Exclusion Criteria:

  1. More than three relapses
  2. Previous ANG1005/GRN1005 treatment
  3. Radiotherapy within 3 months.
  4. Therapy with bevacizumab within 4 weeks prior to screening for recurrent WHO grade III anaplastic glioma patients (Arm 3)
  5. Evidence of significant intracranial hemorrhage
  6. Previous taxane treatment
  7. Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1)
  8. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
  9. Inadequate bone marrow reserve
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01967810
ANG1005-CLN-03
Yes
Not Provided
Not Provided
Angiochem Inc
Angiochem Inc
Not Provided
Study Director: Betty Lawrence Angiochem Inc
Angiochem Inc
January 2016

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