NCT01967810

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

October 9, 2013

Last Update Submit

February 19, 2020

Conditions

GliomaGlioblastomaBrain Tumor, Recurrent

Keywords

gliomaglioblastomabrain cancerbrain tumorrecurrent

Outcome Measures

Primary Outcomes (2)

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

    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)

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

  • PFS3 (Arm 2)

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

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

Secondary Outcomes (7)

  • ORR in Arm 2

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

  • PFS at 3, 6 and 12 months

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

  • Median PFS

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

  • Duration of response

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

  • Overall survival

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

  • +2 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL

ANG1005 administered to bevacizumab-naive recurrent GBM participants

Drug: ANG1005

Arm 2

EXPERIMENTAL

ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants

Drug: ANG1005Drug: Bevacizumab

Arm 3

EXPERIMENTAL

ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants

Drug: ANG1005

Interventions

ANG1005DRUG

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

Also known as: GRN1005
Arm 1Arm 2Arm 3
BevacizumabDRUG

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.

Also known as: Avastin
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Moores UC San Diego Cancer Center

La Jolla, California, 92093-0698, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15323, United States

Location

Univeristy of Texas Health Science Center in San Antonio

San Antonio, Texas, 78229, United States

Location

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, 22903, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Dmello C, Brenner A, Piccioni D, Wen PY, Drappatz J, Mrugala M, Lewis LD, Schiff D, Fadul CE, Chamberlain M, Kesari S, Ahluwalia M, Ghosh D, Sonabend AM, Kumthekar P. Phase II trial of blood-brain barrier permeable peptide-paclitaxel conjugate ANG1005 in patients with recurrent high-grade glioma. Neurooncol Adv. 2024 Dec 14;6(1):vdae186. doi: 10.1093/noajnl/vdae186. eCollection 2024 Jan-Dec.

    PMID: 39713041DERIVED

Related Links

MeSH Terms

Conditions

GliomaGlioblastomaBrain NeoplasmsRecurrence

Interventions

paclitaxel-Angiopep-2 conjugateBevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytomaCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Betty Lawrence

    Angiochem Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 23, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2016

Study Completion

September 1, 2017

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

US(12)