GlioblastomaPhase 2NCT02014844
Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma
A Phase 2 study testing 250 mg/m2 aldoxorubicin and 350 mg/m2 aldoxorubicin in people with Glioblastoma, run by ImmunityBio, Inc. at 4 sites in United States.
Trial summary
This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with glioblastoma who have progressed following surgery and prior treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- 250 mg/m2 aldoxorubicin and 350 mg/m2 aldoxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older; male or female
- Histologically or cytologically confirmed unresectable GBM. Subjects with recurrent disease whose prior pathology demonstrated GBM will not need to be re-biopsied. Subjects with prior low-grade glioma or anaplastic glioma are eligible if histological assessment demonstrates transformation into GBM.
- Cancer progression after treatment with the following: surgery, radiation therapy and temozolomide as first line treatment with no other therapy prior to tumor recurrence.
- Radiographic progression by RANO Working Group Criteria will be confirmed by Imaging Endpoints, a central imaging vendor.
- By tumor biopsy if conducted within 4 weeks of randomization.
- An interval of at least 12 weeks after last dose of radiation and temozolomide is required, unless cancer progression is proven by diagnostic tumor biopsy. If temozolomide is being used in a maintenance phase, there must be a 28-day washout period prior to Randomization.
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- Stable or decreasing dose of corticosteroids for at least 7 days prior to randomization.
- Capable of providing informed consent and complying with trial procedures.
- Karnofsky Performance Status 70 or above.
- ECOG performance status 0-2.
- Life expectancy 8 or more weeks.
- Measurable tumor lesions according to RANO working Group Criteria.
- In the case that there is "non-measurable" disease due to a radical surgical resection during screening, the subject still qualifies if Inclusion #3(b) is met.
- Women must not be able to become pregnant for the duration of the study.
- Women of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- Geographically accessible to site, i.e. the ability to come to the study site for each scheduled appointment and evaluation.
Who cannot join
- Prior exposure to the an anthracycline.
- Any therapeutic regimen for treatment of recurrent tumor after first line treatment with surgery, radiation and temozolomide.
- Prior treatment with bevacizumab or an experimental anti-angiogenic agent.
- Palliative surgery and/or radiation treatment less than 4 weeks to randomization.
- Exposure to any investigational agent within 30 days of Randomization.
- History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for 3 or more years.
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- Laboratory values: screening serum creatinine > 1.5xULN, ALT > 2.5xULN, total bilirubin > 1.5xULN, ANC < 1500/mm3, platelet concentrations < 100,000/mm3, absolute lymphocyte count < 1000/mm3, hematocrit level < 27% for females or < 30% for males, serum albumin ≤ 2.5 g/dL, PT/INR 1.5xULN or >3xULN on anticoagulant with no evidence of active bleeding.
- Evidence of CNS hemorrhage CTCAE ≥ grade 2 on baseline MRI.
- Clinically evident congestive heart failure > class II of the NYHA guidelines.
- Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrythmias classified as Lown III, IV or V.
- History or signs of active coronary artery disease with or without angina pectoris.
- Serious myocardial dysfunction defined as ultrasound-determined LVEF < 45% of predicted institutional normal value.
- Baseline ATc>470 msec and/or previous history of QT prolongation.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals, or anti-fungals.
- History of HIV infection.
- Major surgery, except diagnostic tumor biopsy, within 4 weeks of randomization.
- Any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- Any condition that is unstable and could jeopardize the subject's participation in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Oncology-Austin Midtown
Austin, Texas, 78705
City of Hope National Medical Center
Duarte, California, 91010
Ochsner Health System
New Orleans, Louisiana, 70115-6969
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: An Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of Aldoxorubicin in Subjects With Unresectable Glioblastoma Whose Tumors Have Progressed Following Prior Treatment With Surgery, Radiation and Temozolomide
This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with glioblastoma who have progressed following surgery and prior treatments.
Read the detailed description
This is a second line open-labeled pilot phase 2 study in subjects with glioblastoma whose tumors have progressed following prior treatment with surgery, radiation and Temozolomide. Patients who have received avastin as a second-line treatment are not eligible for this study.
- Conditions
- Glioblastoma
- Being tested
- 250 mg/m2 aldoxorubicin, 350 mg/m2 aldoxorubicin
- Keywords
- glioblastoma, aldoxorubicin, temozolomide, brain cancer, brain tumor
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 mg/m2 aldoxorubicinDrug
Also called INNO-206
350 mg/m2 aldoxorubicinDrug
Also called INNO-206
| Study group | Role | What they receive |
|---|---|---|
| 250 mg/m2 aldoxorubicin | Experimental | Subjects received 250 mg/m2 aldoxorubicin IV. Receives: Drug: 250 mg/m2 aldoxorubicin |
| 350 mg/m2 aldoxorubicin | Experimental | Subjects received 350 mg/m2 aldoxorubicin IV. Receives: Drug: 350 mg/m2 aldoxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (Complete Response and Partial Response)
ORR was defined as the proportion of patients with objective CR or PR by RANO working group criteria.
CR: required all the following: complete disappearance of all enhancing measurable/ non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Patients with non-measurable disease only cannot have a CR.
PR: Requires all of the following: ≥50% decrease compared with baseline sustained for at least 4 weeks; no PD of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan; and stable or improved clinically. Patients with non-measurable disease only can't have a PR.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014844
- Sponsor's protocol ID
- ALDOXORUBICIN-P2-GBM-01
- Status last verified
- Sep 2015
- First submitted
- 9 Dec 2013
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of Aldoxorubicin in Subjects With Unresectable Glioblastoma Whose Tumors Have Progressed Following Prior Treatment With Surgery, Radiation and Temozolomide
- ClinicalTrials.gov ID
- NCT02014844
- Acronym / sponsor ID
- ALDOXORUBICIN-P2-GBM-01
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, aldoxorubicin, temozolomide, brain cancer, brain tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Posted 29 May 2024
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 pilot study to determine the efficacy and safety of aldoxorubicin in subjects with glioblastoma who have progressed following surgery and prior treatments.
Detailed description
This is a second line open-labeled pilot phase 2 study in subjects with glioblastoma whose tumors have progressed following prior treatment with surgery, radiation and Temozolomide. Patients who have received avastin as a second-line treatment are not eligible for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 250 mg/m2 aldoxorubicin | Experimental | Drug: 250 mg/m2 aldoxorubicinSubjects received 250 mg/m2 aldoxorubicin IV. |
| 350 mg/m2 aldoxorubicin | Experimental | Drug: 350 mg/m2 aldoxorubicinSubjects received 350 mg/m2 aldoxorubicin IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 years or older; male or female
- Histologically or cytologically confirmed unresectable GBM. Subjects with recurrent disease whose prior pathology demonstrated GBM will not need to be re-biopsied. Subjects with prior low-grade glioma or anaplastic glioma are eligible if histological assessment demonstrates transformation into GBM.
- Cancer progression after treatment with the following: surgery, radiation therapy and temozolomide as first line treatment with no other therapy prior to tumor recurrence.
- An interval of at least 12 weeks after last dose of radiation and temozolomide is required, unless cancer progression is proven by diagnostic tumor biopsy. If temozolomide is being used in a maintenance phase, there must be a 28-day washout period prior to Randomization.
- Stable or decreasing dose of corticosteroids for at least 7 days prior to randomization.
Key exclusion criteria (18 listed)
- Prior exposure to the an anthracycline.
- Any therapeutic regimen for treatment of recurrent tumor after first line treatment with surgery, radiation and temozolomide.
- Prior treatment with bevacizumab or an experimental anti-angiogenic agent.
- Palliative surgery and/or radiation treatment less than 4 weeks to randomization.
- Exposure to any investigational agent within 30 days of Randomization.
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 |
|---|---|---|
| 250 mg/m2 aldoxorubicinAlso: INNO-206 | Drug | 250 mg/m2 aldoxorubicin |
| 350 mg/m2 aldoxorubicinAlso: INNO-206 | Drug | 350 mg/m2 aldoxorubicin |
Primary outcome
Objective Response Rate (Complete Response and Partial Response)
Time frame: up to 6 months
ORR was defined as the proportion of patients with objective CR or PR by RANO working group criteria. CR: required all the following: complete disappearance of all enhancing measurable/ non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Patients with non-measurable disease only cannot have a CR. PR: Requires all of the following: ≥50% decrease compared with baseline sustained for at least 4 weeks; no PD of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan; and stable or improved clinically. Patients with non-measurable disease only can't have a PR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 250 mg/m2 aldoxorubicin and 350 mg/m2 aldoxorubicin in people with Glioblastoma, run by ImmunityBio, Inc. at 4 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 16 inclusion and 18 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Complete Response and Partial Response) (time frame: up to 6 months). 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 29 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.