Skip to main content
OpenTrials
Completed

NCT Number: NCT01967810

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glioma Astrocytoma Brain Diseases Brain Neoplasms Brain Tumor, Recurrent Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Glioblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moores UC San Diego Cancer Center, La Jolla, California, United States

Loading trial locations.

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old
  • GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed
  • Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
  • Neurologically stable
  • For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy
  • Karnofsky performance status (KPS) ≥ 80
  • Expected survival of at least 3 months

Exclusion criteria

  • More than three relapses
  • Previous ANG1005/GRN1005 treatment
  • Radiotherapy within 3 months.
  • Therapy with bevacizumab within 4 weeks prior to Day 1 of treatment for recurrent WHO grade III anaplastic glioma patients (Arm 3)
  • Evidence of significant intracranial hemorrhage
  • Previous taxane treatment
  • Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1)
  • NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
  • Inadequate bone marrow reserve
  • Any evidence of severe or uncontrolled diseases
  • Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV
  • Known severe hypersensitivity or allergy to paclitaxel or any of its components

Treatment and study plan

ANG1005

Drug

ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks

Other names: GRN1005

Bevacizumab

Drug

For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.

Other names: Avastin

Primary outcomes

  1. Objective Response Rate (ORR) (Arms 1 and 3)

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma World Health Organization (WHO) Grade III patients (Arm 3)

  2. PFS3 (Arm 2)

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)

Secondary outcomes

  1. ORR in Arm 2

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the ORR in Arm 2

  2. PFS at 3, 6 and 12 months

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    • 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

  3. Median PFS

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the median progression-free survival in each arm

  4. Duration of response

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the median duration of response in each arm

  5. Overall survival

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the median overall survival in each arm

  6. Safety and tolerability

    Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

    To determine the number of participants with adverse events

  7. Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC])

    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)

    To determine the drug concentration and distribution in the blood (plasma)

Sponsors and collaborators

Lead sponsor

Angiochem Inc

Industry

Registry information

Official study title

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 23, 2013
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.