GliomaPhase 2NCT01967810
ANG1005 in Patients With Recurrent High-Grade Glioma
A Phase 2 study testing ANG1005 and Bevacizumab in people with Glioma and Glioblastoma, run by Angiochem Inc at 12 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, Brain Tumor, Recurrent
- What is being tested?
- ANG1005 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2013to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Moores UC San Diego Cancer Center
La Jolla, California, 92093-0698
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15323
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, 78229
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: A Phase II, Open-Label, Multi-Center Study of 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.
Read the detailed description
See above.
- Conditions
- Glioma, Glioblastoma, Brain Tumor, Recurrent
- Being tested
- ANG1005, Bevacizumab
- Keywords
- glioma, glioblastoma, brain cancer, brain tumor, recurrent
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG1005Drug
Also called GRN1005
ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
BevacizumabDrug
Also called Avastin
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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ANG1005 administered to bevacizumab-naive recurrent GBM participants Receives: Drug: ANG1005 |
| Arm 2 | Experimental | ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants Receives: Drug: ANG1005; Drug: Bevacizumab |
| Arm 3 | Experimental | ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants Receives: Drug: ANG1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary outcomes (7)
ORR in Arm 2
To determine the ORR in Arm 2
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
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
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median PFS
To determine the median progression-free survival in each arm
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of response
To determine the median duration of response in each arm
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Overall survival
To determine the median overall survival in each arm
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Safety and tolerability
To determine the number of participants with adverse events
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiochem Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty Lawrence, Study director, Angiochem Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967810
- Sponsor's protocol ID
- ANG1005-CLN-03
- Status last verified
- Feb 2020
- First submitted
- 9 Oct 2013
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39713041
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
- ClinicalTrials.gov ID
- NCT01967810
- Acronym / sponsor ID
- ANG1005-CLN-03
- Conditions
- Glioma, Glioblastoma, Brain Tumor, Recurrent
- Keywords
- glioma, glioblastoma, brain cancer, brain tumor, recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Angiochem IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ANG1005ANG1005 administered to bevacizumab-naive recurrent GBM participants |
| Arm 2 | Experimental | Drug: ANG1005, Drug: BevacizumabANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants |
| Arm 3 | Experimental | Drug: ANG1005ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANG1005Also: GRN1005ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks | Drug | Arm 1, Arm 2, Arm 3 |
| BevacizumabAlso: AvastinFor 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. | Drug | Arm 2 |
Primary outcome
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)
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)
7 secondary outcomes
ORR in Arm 2
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
PFS at 3, 6 and 12 months
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median PFS
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of response
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Overall survival
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Safety and tolerability
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 39713041Dmello 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.
- A Phase I sudy of ANG1005 (GRN1005) in recurrent malignant gliomaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Lawrence study director
Angiochem Inc
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANG1005 and Bevacizumab in people with Glioma and Glioblastoma, run by Angiochem Inc at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01967810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.