Clinical trial NCT01967810: ANG1005 in Patients With Recurrent High-Grade Glioma
Official title: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Glioblastoma
Brain Tumor, Recurrent
Keywords: glioma
glioblastoma
brain cancer
brain tumor
recurrent
Lead sponsor: Angiochem Inc
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See above.

Eligibility criteria: 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) ≥ 80
7. Expected survival of at least 3 months

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 Day 1 of treatment 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
10. Any evidence of severe or uncontrolled diseases
11. Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV
12. Known severe hypersensitivity or allergy to paclitaxel or any of its components

Primary outcomes:
measure: Objective Response Rate (ORR) (Arms 1 and 3)
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: PFS3 (Arm 2)
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary outcomes:
measure: ORR in Arm 2
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: PFS at 3, 6 and 12 months
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Median PFS
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Duration of response
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Overall survival
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Safety and tolerability
timeFrame: Upon enrollment through end of study period (1 year after last patient is enrolled)
measure: Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC])
timeFrame: 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)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Univeristy of Texas Health Science Center in San Antonio
state: Texas
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Angiochem Inc
name: Betty Lawrence
role: STUDY_DIRECTOR
References: