Glioblastoma MultiformePhase 1NCT01800695
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
A Phase 1 study testing ABT-414, Temozolomide and Whole Brain Radiation in people with Glioblastoma Multiforme, run by AbbVie.
Trial summary
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ABT-414, Temozolomide and Whole Brain Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2013to 19 Jun 2017
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glioblastoma Multiforme (GBM)
- 70 or above on Karnofsky Performance Status
- Adequate bone marrow function
- Recurrent GBM per RANO criteria
- Subjects must have confirmed EGFR amplification by central lab
Who cannot join
- For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
- For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
- Allergies to temozolomide, dacarbazine, IgG containing agents
- Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
- Subjects that have had more than one disease recurrence
About this study
Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ABT-414, Temozolomide, Whole Brain Radiation
- Keywords
- GBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-414Drug
Also called Depatuxizumab Mafodotin
ABT-414 will be administered by intravenous infusion
TemozolomideDrug
Temozolomide will be administered per label and local prescribing regulations.
Whole Brain RadiationRadiation
Whole Brain radiation will be administered in 30 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | ABT-414 in combination with radiation and temozolomide Receives: Drug: ABT-414; Drug: Temozolomide; Radiation: Whole Brain Radiation |
| Arm B | Experimental | ABT-414 in combination with temozolomide Receives: Drug: ABT-414; Drug: Temozolomide |
| Arm C | Experimental | ABT-414 monotherapy Receives: Drug: ABT-414 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with adverse events
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Measured: Every week for an expected average of 34 weeks
Maximum concentration of ABT-414
Measurement of the maximum concentration of ABT- 414 in the blood
Measured: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Number of Dose Limiting Toxicities
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Measured: Every week for an expected average of 34 weeks
Minimum Concentration of ABT-414
Measurement of the minimum concentration of ABT-414 in the blood
Measured: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Half-life of ABT-414
Measurement of the clearance of ABT-414
Measured: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Secondary outcomes (3)
Biomarker EGFR expression
Assessment of tumor biomarkers that may correlate with efficacy.
Measured: At screening and post-study
Progression Free Survival
Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.
Measured: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.
Overall Survival
The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months
Measured: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study start2 Apr 2013
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Earle Bain, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800695
- Sponsor's protocol ID
- M12-356
- Other IDs
- 2012-003884-23
- Status last verified
- Jul 2017
- First submitted
- 5 Feb 2013
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lassman AB, Roberts-Rapp L, Sokolova I, Song M, Pestova E, Kular R, Mullen C, Zha Z, Lu X, Gomez E, Bhathena A, Maag D, Kumthekar P, Gan HK, Scott AM, Guseva M, Holen KD, Ansell PJ, van den Bent MJ. Comparison of Biomarker Assays for EGFR: Implications for Precision Medicine in Patients with Glioblastoma. Clin Cancer Res. 2019 Jun 1;25(11):3259-3265. doi: 10.1158/1078-0432.CCR-18-3034. Epub 2019 Feb 22.
PubMed 30796037Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
PubMed 29982805Goss GD, Vokes EE, Gordon MS, Gandhi L, Papadopoulos KP, Rasco DW, Fischer JS, Chu KL, Ames WW, Mittapalli RK, Lee HJ, Zeng J, Roberts-Rapp LA, Loberg LI, Ansell PJ, Reilly EB, Ocampo CJ, Holen KD, Tolcher AW. Efficacy and safety results of depatuxizumab mafodotin (ABT-414) in patients with advanced solid tumors likely to overexpress epidermal growth factor receptor. Cancer. 2018 May 15;124(10):2174-2183. doi: 10.1002/cncr.31304. Epub 2018 Mar 13.
PubMed 29533458
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01800695
- Acronym / sponsor ID
- M12-356
- Conditions
- Glioblastoma Multiforme
- Keywords
- GBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2013 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 28 Feb 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 study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: ABT-414, Drug: Temozolomide, Radiation: Whole Brain RadiationABT-414 in combination with radiation and temozolomide |
| Arm B | Experimental | Drug: ABT-414, Drug: TemozolomideABT-414 in combination with temozolomide |
| Arm C | Experimental | Drug: ABT-414ABT-414 monotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Glioblastoma Multiforme (GBM)
- 70 or above on Karnofsky Performance Status
- Adequate bone marrow function
- Recurrent GBM per RANO criteria
- Subjects must have confirmed EGFR amplification by central lab
Key exclusion criteria (5 listed)
- For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
- For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
- Allergies to temozolomide, dacarbazine, IgG containing agents
- Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
- Subjects that have had more than one disease recurrence
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 |
|---|---|---|
| ABT-414Also: Depatuxizumab MafodotinABT-414 will be administered by intravenous infusion | Drug | Arm A, Arm B, Arm C |
| TemozolomideTemozolomide will be administered per label and local prescribing regulations. | Drug | Arm A, Arm B |
| Whole Brain RadiationWhole Brain radiation will be administered in 30 fractions. | Radiation | Arm A |
Primary outcome
Number and percentage of participants with adverse events
Time frame: Every week for an expected average of 34 weeks
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Maximum concentration of ABT-414
Time frame: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the maximum concentration of ABT- 414 in the blood
Number of Dose Limiting Toxicities
Time frame: Every week for an expected average of 34 weeks
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Minimum Concentration of ABT-414
Time frame: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the minimum concentration of ABT-414 in the blood
Half-life of ABT-414
Time frame: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the clearance of ABT-414
3 secondary outcomes
Biomarker EGFR expression
Time frame: At screening and post-study
Progression Free Survival
Time frame: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.
Overall Survival
Time frame: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination
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 21 Nov 2017.
- Derived from this study: PubMed 30796037Lassman AB, Roberts-Rapp L, Sokolova I, Song M, Pestova E, Kular R, Mullen C, Zha Z, Lu X, Gomez E, Bhathena A, Maag D, Kumthekar P, Gan HK, Scott AM, Guseva M, Holen KD, Ansell PJ, van den Bent MJ. Comparison of Biomarker Assays for EGFR: Implications for Precision Medicine in Patients with Glioblastoma. Clin Cancer Res. 2019 Jun 1;25(11):3259-3265. doi: 10.1158/1078-0432.CCR-18-3034. Epub 2019 Feb 22.
- Derived from this study: PubMed 29982805Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
- Derived from this study: PubMed 29533458Goss GD, Vokes EE, Gordon MS, Gandhi L, Papadopoulos KP, Rasco DW, Fischer JS, Chu KL, Ames WW, Mittapalli RK, Lee HJ, Zeng J, Roberts-Rapp LA, Loberg LI, Ansell PJ, Reilly EB, Ocampo CJ, Holen KD, Tolcher AW. Efficacy and safety results of depatuxizumab mafodotin (ABT-414) in patients with advanced solid tumors likely to overexpress epidermal growth factor receptor. Cancer. 2018 May 15;124(10):2174-2183. doi: 10.1002/cncr.31304. Epub 2018 Mar 13.
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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.
Earle Bain, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-414, Temozolomide and Whole Brain Radiation in people with Glioblastoma Multiforme, run by AbbVie.
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 5 inclusion and 5 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 21 Nov 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number and percentage of participants with adverse events (time frame: Every week for an expected average of 34 weeks). The study lists 5 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 NCT01800695, which also lists 3 linked publications.
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 21 Nov 2017.