Brain and Central Nervous System TumorsEarly Phase 1NCT03965494
AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery
A Early Phase 1 study testing BGB 324 (before surgery) and BGB 324 (after surgery) in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 6 sites in United States.
Trial summary
This phase I trial studies how well AXL inhibitor BGB324 works in treating participants with glioblastoma that has come back who are undergoing surgery. AXL inhibitor BGB324 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- BGB 324 (before surgery) and BGB 324 (after surgery)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Jan 2020to 31 Oct 2023
- Phase
- Early 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histologically confirmed glioblastoma (GBM) that is progressive or recurrent following radiation therapy +/- chemotherapy. Patients with previous low-grade glioma who progressed after radiation therapy (RT)/chemotherapy and are biopsied and found to have GBM/gliosarcoma (GS) are eligible
- Patients must have measurable, supratentorial contrast-enhancing progressive or recurrent glioblastoma or gliosarcoma by magnetic resonance imaging (MRI) within 21 days of starting treatment. Patient must be able to tolerate MRIs
- May have had treatment for no more than 2 prior relapses
- Must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of GBM or GS, completed and signed by a pathologist. Sites must agree to provide this form within 14 days after treatment start. Availability of tissue is not a requirement for study participation
- The following intervals from previous treatments are required to be eligible:
- 12 weeks from the completion of radiation
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- 6 weeks from a nitrosourea chemotherapy or mitomycin C
- 3 weeks from a non-nitrosourea chemotherapy
- 4 weeks from any investigational (not Food and Drug Administration [FDA]-approved) agents
- 2 weeks from administration of a non-cytotoxic, FDA-approved agent, e.g., erlotinib, hydroxychloroquine, etc.)
- 4 weeks from prior antiangiogenesis therapy (approved or investigational) (e.g., bevacizumab, aflibercept, ramucirumab, cediranib, cabozantinib, etc.)
- 4 weeks from any immunotherapy intervention
- Patients must be undergoing surgery that is clinically indicated as determined by their care providers. Patients must be eligible for surgical resection according to the following criteria:
- Expectation that the surgeon is able to resect 0.05-0.10 cm^3 (50-100 mg) of tumor from enhancing tumor and at least 0.05-0.10 cm^3 (50-100 mg) from non-enhancing tumor with low risk of inducing neurological injury
- Must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin >= 9 g/dL
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal
- Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73m^2 for patients with creatinine levels above institutional normal
- Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal
- Must have a 12-lead electrocardiogram with a measurable corrected QT using Fridericia's correction formula (QTcF) =< 450 msec
- Must be able to provide written informed consent
- Women of childbearing potential must have a negative serum pregnancy test prior to study entry. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and through 4 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of BGB324 administration
- Must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for >= five years
- Must be able to swallow whole capsules
Who cannot join
- Patients receiving any other investigational agents are ineligible
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to BGB324 are ineligible. The investigator brochure can be referenced for more information
- Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with an EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to treatment start
- Patients with a history of bleeding diathesis are ineligible
- Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
- Patients considered at risk of QTc induced arrhythmias or uncontrolled or significant cardiovascular disease, including, but not limited to, any of the following are ineligible:
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- Abnormal left ventricular ejection fraction on echocardiography (less than the lower limit of normal for a subject of that age at the treating institution or < 45%)
- History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
- Congestive cardiac failure of > grade 2 severity according to the New York Heart Association as defined by symptomatic at less than ordinary levels of activity
- Unstable cardiac disease including unstable angina or hypertension as defined by the need for change in medication within the last 3 months
- History or presence of bradycardia (=< 60 beats per minute [bpm]) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias as defined by the need for treatment
- Current treatment with any agent known to cause torsade de points which cannot be discontinued at least two weeks prior to treatment
- Known family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy
- Previous history of drug-induced QTc prolongation
- Screening 12-lead electrocardiogram (ECG) with a measurable QTcF > 450 ms
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
- Pregnant women are excluded from this study because the effects of BGB324 on a fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BGB324, breastfeeding should be discontinued if the mother is treated with BGB324
- Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:
- A stable regimen of highly active anti-retroviral therapy (HAART) not containing a strong inducer or inhibitor of CYP2C9
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
- A CD4 count above 250 cells/uL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based test
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294
Henry Ford Hospital
Detroit, Michigan, 48202
Memorial Sloan Kettering
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Surgical PK Study of BGB324 in Recurrent Glioblastoma Patients
This phase I trial studies how well AXL inhibitor BGB324 works in treating participants with glioblastoma that has come back who are undergoing surgery. AXL inhibitor BGB324 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the penetration of AXL inhibitor BGB324 (BGB324) across the blood brain barrier measured by pharmacokinetics/drug concentration of 1.0 uM in tissue resected from a contrast enhancing region of the tumor in 60% of recurrent glioblastoma patients.
SECONDARY OBJECTIVES:
- Determine AXL expression, phosphorylation state (AXL phosphospecific antibody if AXL is inhibited), and circulating soluble AXL levels.
II. Determine the BGB324 concentration in tissue resected from a contrast non-enhancing region of the tumor.
III. Characterize the steady state pharmacokinetics of BGB324 in patients with recurrent glioblastoma.
IV. Estimate safety and tolerability of BGB324 for recurrent glioblastoma. V. Assess the progression-free and overall survival of patients with recurrent glioblastoma.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP A: Participants receive AXL inhibitor BGB324 orally (PO) once daily (QD) on days 1-5, then undergo surgery 3-6 hours after last dose. Within 45 days, participants receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
GROUP B: Participants undergo surgery, then within 45 days receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- BGB 324 (before surgery), BGB 324 (after surgery)
- Keywords
- adult glioblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB 324 (before surgery)Drug
Also called AXL Inhibitor BGB324, Bemcentinib
Given by mouth either BEFORE therapeutic conventional surgery
BGB 324 (after surgery)Drug
Also called AXL Inhibitor BGB324, Bemcentinib
Given by mouth either AFTER therapeutic conventional surgery
| Study group | Role | What they receive |
|---|---|---|
| AXL inhibitor BGB324 then surgery | Experimental | Participants receive AXL inhibitor BGB324 PO QD on days 1-5, then undergo surgery 3-6 hours after last dose. Within 45 days, participants receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: BGB 324 (before surgery) |
| Surgery then AXL inhibitor BGB324 | Experimental | Participants undergo surgery, then within 45 days receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: BGB 324 (after surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve a drug concentration at >= 1.0 uM level in contrast enhancing tumor tissue
Will be estimated using binomial distribution along with 90% confidence interval.
Measured: Up to 1 year
Secondary outcomes (7)
Change in AXL expression level
Change in AXL expression level (ng/mL) from baseline (before intervention) to post-intervention.
Measured: Up to 1 year
Pharmacokinetics as measured by plasma maximum concentration (Cmax) (ug/mL)
Samples for pharmacokinetic analysis will be collected at baseline, prior to dose on day of surgery, at 2, 4, 8, 12, 16, 20, and 24 hours after dosing; on course (C)1 day (D)1, at 2, 4, 6 and 24 hours on C1D15, C2D8, C2D15, prior to starting each course and 30 days post-treatment
Measured: up to 30 days post-treatment
Pharmacokinetics as measured by plasma minimum concentration (Cmin) (ug/mL)
Samples for pharmacokinetic analysis will be collected at baseline, prior to dose on day of surgery, at 2, 4, 8, 12, 16, 20, and 24 hours after dosing; on course (C)1 day (D)1, at 2, 4, 6 and 24 hours on C1D15, C2D8, C2D15, prior to starting each course and 30 days post-treatment
Measured: up to 30 days post-treatment
Pharmacokinetics as measured by area under the curve (AUC) (ug/mL*hr)
Samples for pharmacokinetic analysis will be collected at baseline, prior to dose on day of surgery, at 2, 4, 8, 12, 16, 20, and 24 hours after dosing; on course (C)1 day (D)1, at 2, 4, 6 and 24 hours on C1D15, C2D8, C2D15, prior to starting each course and 30 days post-treatment
Measured: up to 30 days post-treatment
Toxicity as assessed by number of participants experiencing of adverse events
Number of participants experiencing of adverse events grade 3 or higher as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Measured: Up to 1 year
Overall survival
Time until death or the time of last known alive if lost to follow-up. Survival probability and a median time of survival will be estimated using Kaplan-Meier method along with 95% confidence interval.
Measured: up to 1 year
Progression-free survival
Median time of progression-free survival will be estimated using Kaplan-Meier method along with 95% confidence interval. Tumor assessment will be conducted per Response Assessment in Neuro-Oncology (RANO): Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= <50% reduction to <25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status
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 posted29 May 2019
- Study start2 Jan 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer - official close date is 10/31/23
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), BerGenBio ASA
- Responsible party
- Sponsor
- Investigators
- Burt Nabors, MD, Study chair, University of Alabama and Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965494
- Sponsor's protocol ID
- ABTC-1701
- Other IDs
- IRB00184546, UM1CA137443
- Status last verified
- Feb 2024
- First submitted
- 24 May 2019
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Surgical PK Study of BGB324 in Recurrent Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT03965494
- Acronym / sponsor ID
- ABTC-1701
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer - official close date is 10/31/23
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), BerGenBio ASA
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 29 May 2019 (actual)
- 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 phase I trial studies how well AXL inhibitor BGB324 works in treating participants with glioblastoma that has come back who are undergoing surgery. AXL inhibitor BGB324 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the penetration of AXL inhibitor BGB324 (BGB324) across the blood brain barrier measured by pharmacokinetics/drug concentration of 1.0 uM in tissue resected from a contrast enhancing region of the tumor in 60% of recurrent glioblastoma patients.
SECONDARY OBJECTIVES:
- Determine AXL expression, phosphorylation state (AXL phosphospecific antibody if AXL is inhibited), and circulating soluble AXL levels.
II. Determine the BGB324 concentration in tissue resected from a contrast non-enhancing region of the tumor.
III. Characterize the steady state pharmacokinetics of BGB324 in patients with recurrent glioblastoma.
IV. Estimate safety and tolerability of BGB324 for recurrent glioblastoma. V. Assess the progression-free and overall survival of patients with recurrent glioblastoma.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP A: Participants receive AXL inhibitor BGB324 orally (PO) once daily (QD) on days 1-5, then undergo surgery 3-6 hours after last dose. Within 45 days, participants receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
GROUP B: Participants undergo surgery, then within 45 days receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXL inhibitor BGB324 then surgery | Experimental | Drug: BGB 324 (before surgery)Participants receive AXL inhibitor BGB324 PO QD on days 1-5, then undergo surgery 3-6 hours after last dose. Within 45 days, participants receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Surgery then AXL inhibitor BGB324 | Experimental | Drug: BGB 324 (after surgery)Participants undergo surgery, then within 45 days receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Must have histologically confirmed glioblastoma (GBM) that is progressive or recurrent following radiation therapy +/- chemotherapy. Patients with previous low-grade glioma who progressed after radiation therapy (RT)/chemotherapy and are biopsied and found to have GBM/gliosarcoma (GS) are eligible
- Patients must have measurable, supratentorial contrast-enhancing progressive or recurrent glioblastoma or gliosarcoma by magnetic resonance imaging (MRI) within 21 days of starting treatment. Patient must be able to tolerate MRIs
- May have had treatment for no more than 2 prior relapses
- Must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of GBM or GS, completed and signed by a pathologist. Sites must agree to provide this form within 14 days after treatment start. Availability of tissue is not a requirement for study participation
- The following intervals from previous treatments are required to be eligible:
Key exclusion criteria (21 listed)
- Patients receiving any other investigational agents are ineligible
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to BGB324 are ineligible. The investigator brochure can be referenced for more information
- Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with an EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to treatment start
- Patients with a history of bleeding diathesis are ineligible
- Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
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 |
|---|---|---|
| BGB 324 (before surgery)Also: AXL Inhibitor BGB324, BemcentinibGiven by mouth either BEFORE therapeutic conventional surgery | Drug | AXL inhibitor BGB324 then surgery |
| BGB 324 (after surgery)Also: AXL Inhibitor BGB324, BemcentinibGiven by mouth either AFTER therapeutic conventional surgery | Drug | Surgery then AXL inhibitor BGB324 |
Primary outcome
Proportion of patients who achieve a drug concentration at >= 1.0 uM level in contrast enhancing tumor tissue
Time frame: Up to 1 year
Will be estimated using binomial distribution along with 90% confidence interval.
7 secondary outcomes
Change in AXL expression level
Time frame: Up to 1 year
Pharmacokinetics as measured by plasma maximum concentration (Cmax) (ug/mL)
Time frame: up to 30 days post-treatment
Pharmacokinetics as measured by plasma minimum concentration (Cmin) (ug/mL)
Time frame: up to 30 days post-treatment
Pharmacokinetics as measured by area under the curve (AUC) (ug/mL*hr)
Time frame: up to 30 days post-treatment
Toxicity as assessed by number of participants experiencing of adverse events
Time frame: Up to 1 year
Overall survival
Time frame: up to 1 year
Progression-free survival
Time frame: up to 1 year
Results and safety
The study was stopped early (reason given: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer - official close date is 10/31/23). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Burt Nabors, MD study chair
University of Alabama and Birmingham
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BGB 324 (before surgery) and BGB 324 (after surgery) in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 6 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 27 inclusion and 21 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: stopped early, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer - official close date is 10/31/23). Results are not available in the source record.
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?
Proportion of patients who achieve a drug concentration at >= 1.0 uM level in contrast enhancing tumor tissue (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 8 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.