Recurrent GlioblastomaPhase 2NCT03033524
Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma
A Phase 2 study testing TTAC-0001 in people with Recurrent Glioblastoma, run by PharmAbcine.
Trial summary
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial Study objective: 1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma. 2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma. 3. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- TTAC-0001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2016to 2 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female patients ≥19 years old
- Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
- At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
- Karnofsky Performance Status (KPS) ≥ 80
- A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
- At least 12 weeks of expected survival time
- Signed informed consent
Who cannot join
- Diagnosed with other malignant tumor within 2years
- Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder
- Not recovered grade 2 AE due to previous CCRT
- Major surgery or other investigational drug treatment within 4 weeks
- Pregnant/lactating female and female/male potential childbearing without contraception
- Severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug
- Expectation of poor compliance
- Previous therapy with VEGF targeted agent
About this study
Official title: A Multicenter, 3-Arm, Open-Label, Phase Ⅱa Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
Study objective:
Read more
- Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
- Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
- Exploratory
- To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma
- To evaluate pharmacodynamic (PD) parameters by clinical biomarker test
Study Methodology
Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case.
A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.
- Conditions
- Recurrent Glioblastoma
- Being tested
- TTAC-0001
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTAC-0001Drug
Also called Tanibirumab
Calculated amount of drug will be diluted with normal saline and administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle. Receives: Drug: TTAC-0001 |
| Cohort 2 | Experimental | Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle. Receives: Drug: TTAC-0001 |
| Cohort 3 | Experimental | Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle. Receives: Drug: TTAC-0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: up to 1 year
Secondary outcomes (4)
PFS at 6-month time point
Measured: 6 months
Objective response rate (ORR)
The rate of complete response and partial response assessed according to RANO criteria.
Measured: up to 1 year
Disease control rate(DCR)
The rate of complete response(CR), partial response(PR) and stable disease(SD) assessed according to RANO criteria.
Measured: up to 1 year
Overall survival(OS)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start4 Feb 2016
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmAbcine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033524
- Sponsor's protocol ID
- PMC_TTAC-0001_02
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 3-Arm, Open-Label, Phase Ⅱa Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT03033524
- Acronym / sponsor ID
- PMC_TTAC-0001_02
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PharmAbcineIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 26 Jan 2017 (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.
Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
Study objective:
- Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
- Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
- Exploratory
- To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma
- To evaluate pharmacodynamic (PD) parameters by clinical biomarker test
Study Methodology
Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case.
A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TTAC-0001Patients will be treated with 8mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle. |
| Cohort 2 | Experimental | Drug: TTAC-0001Patients will be treated with 12mg/kg of TTAC-0001 on day 1, day 8 and day 15 in every 4 weeks of cycle. |
| Cohort 3 | Experimental | Drug: TTAC-0001Patients will be treated with 12mg/kg of TTAC-0001 weekly in every 4 weeks of cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both male and female patients ≥19 years old
- Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
- At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
- Karnofsky Performance Status (KPS) ≥ 80
- A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
Key exclusion criteria (8 listed)
- Diagnosed with other malignant tumor within 2years
- Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder
- Not recovered grade 2 AE due to previous CCRT
- Major surgery or other investigational drug treatment within 4 weeks
- Pregnant/lactating female and female/male potential childbearing without contraception
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 |
|---|---|---|
| TTAC-0001Also: TanibirumabCalculated amount of drug will be diluted with normal saline and administered intravenously. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Adverse events
Time frame: up to 1 year
4 secondary outcomes
PFS at 6-month time point
Time frame: 6 months
Objective response rate (ORR)
Time frame: up to 1 year
Disease control rate(DCR)
Time frame: up to 1 year
Overall survival(OS)
Time frame: up to 1 year
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 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTAC-0001 in people with Recurrent Glioblastoma, run by PharmAbcine.
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 8 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Adverse events (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.