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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01967810
Other study ID # ANG1005-CLN-03
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2013
Est. completion date September 2017

Study information

Verified date February 2020
Source Angiochem Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

See above.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date September 2017
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Emily Couric Clinical Cancer Center Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Moores UC San Diego Cancer Center La Jolla California
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States UPMC Cancer Center Pittsburgh Pennsylvania
United States Univeristy of Texas Health Science Center in San Antonio San Antonio Texas
United States Seattle Cancer Care Alliance Seattle Washington
United States University of Washington Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Angiochem Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 ORR in Arm 2 To determine the ORR in Arm 2 Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary PFS at 3, 6 and 12 months 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
Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Median PFS To determine the median progression-free survival in each arm Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Duration of response To determine the median duration of response in each arm Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Overall survival To determine the median overall survival in each arm Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Safety and tolerability To determine the number of participants with adverse events Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC]) To determine the drug concentration and distribution in the blood (plasma) 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)
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