ANG1005 in Patients With Recurrent High-Grade Glioma

Part of paid clinical trials in La Jolla, California.

Sponsor
Angiochem Inc
Study ID
NCT01967810
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 23, 2013
Start date
Oct 31, 2013
Status verified
Feb 2020
Primary completion
Feb 29, 2016
Completion
Sep 30, 2017

Study Design

Enrollment
73 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    ANG1005 administered to bevacizumab-naive recurrent GBM participants
  • Experimental: Arm 2
    ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
  • Experimental: Arm 3
    ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants

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) ]

Locations (12)

FacilityCityStateZIPSite coordinators
Moores UC San Diego Cancer CenterLa JollaCalifornia92093-0698-
Northwestern UniversityChicagoIllinois60611-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Norris Cotton Cancer CenterLebanonNew Hampshire03756-
Cleveland ClinicClevelandOhio44195-
UPMC Cancer CenterPittsburghPennsylvania15323-
Univeristy of Texas Health Science Center in San AntonioSan AntonioTexas78229-
Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22903-
Seattle Cancer Care AllianceSeattleWashington98109-1023-
University of Washington Medical CenterSeattleWashington98195-

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