High Grade GliomaPhase 1NCT02022644
Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma
A Phase 1 study testing nanoliposomal irinotecan in people with High Grade Glioma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single center, dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery (CED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- nanoliposomal irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2014to 31 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiographically proven recurrent, intracranial high grade glioma will be eligible for this protocol. Patients must have evidence of tumor progression as determined by the Revised Assessment in Neuro-Oncology RANO criteria following standard therapy.
- High grade glioma includes glioblastoma multiforme (GBM), Gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma not otherwise specified. (NOS)
- Magnetic resonance imaging (MRI) must be performed within 21 days prior to enrollment, and patients who are receiving steroids must be stable or decreasing for at least 5 days prior to imaging. If the steroid dose is increased between the date of imaging and enrollment, a new baseline MRI is required.
- Patients must have completed only 1 prior course of radiation therapy and must have experienced an interval of greater than 12 weeks from the completion of radiation therapy to study entry.
- Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a high grade glioma is made.
- There is no limit as to the number of prior treatments but patients must have radiographic evidence of progressive disease
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- Recurrent tumor must be a solid, single, supratentorial, contrast-enhancing HGG which have a tumor diameter no larger than 4cm or volume of 34cm3
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be> 18 years old, and with a life expectancy > 8 weeks
- Patients with Karnofsky performance status of >= 70.
- At the time of registration: Patients must have recovered from the toxic effects of prior therapy: > 10 days from any noncytotoxic investigational agent, >28 days from prior cytotoxic therapy or Avastin, >14 days from vincristine, >42 days from nitrosoureas, >21 days from procarbazine administration, and >7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
- Requirements for organ and marrow function as follows:
- Adequate bone marrow function:
- leukocytes > 3,000/microliter (mcL)
- absolute neutrophil count > 1,500/mcL
- platelets > 100,000/mcL
- Adequate hepatic function:
- total bilirubin within normal institutional limits
- aspartate aminotransferase (AST) < 2.5 X institutional upper limit of normal
- alanine aminotransferase (ALT) < 2.5 X institutional upper limit of normal
- Adequate renal function:
- creatinine within normal institutional limits OR
- creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- Adequate coagulation function
- International Normalized Ratio (INR) < 2.0
- partial thromboplastin time (PTT) <= institution's upper limit of normal, unless receiving therapeutic low molecular weight heparin.
- The effects of nano liposomal irinotecan on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence, etc. prior to study entry, for the duration of study participation, and for 6 months post drug administration. 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
- Women of childbearing potential must have a negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test documented within 14 days prior to treatment.
- Patients with prior therapy that included interstitial brachytherapy, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either Positron Emission Tomography (PET) or Thallium scanning, MR spectroscopy or surgical documentation of disease
- Patients must be able to have MRI brain imaging.
- UGT1A1 genotyping will be sent for testing at screening, but results do not have to be known before starting treatment
Who cannot join
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- HIV-positive patients on combination antiretroviral therapy are ineligible.
- Contrast-enhancing tumor which crosses the midline.
- Multi-focal disease.
- Nonparenchymal tumor dissemination (e.g., subependymal or leptomeningeal)
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- History of hypersensitivity reactions to products containing irinotecan (irinotecan), topotecan or other topoisomerase inhibitors, gadolinium contrast agents or lipid products.
- Ongoing treatment with cytotoxic therapy.
- Patients may not be on an enzyme-inducing anti-epileptic drug (EIAED). If previously on an EIAED, patient must be off for at least 10 days prior to CED infusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase I Study of Convection-Enhanced Delivery of Liposomal-Irinotecan Using Real-Time Imaging With Gadolinium In Patients With Recurrent High Grade Glioma
This is a single center, dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery (CED).
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety and tolerability of liposomal-irinotecan with gadolinium given by intra tumoral real-time convection enhanced delivery in patients with recurrent high grade glioma (HGG).
SECONDARY OBJECTIVES:
- To optimize the magnetic resonance image-guided intracranial injection procedure in patients with recurrent HGG by correlating the observed distribution of gadolinium to pre-treatment modeling of the drug distribution utilizing predictive imaging software.
EXPLORATORY OBJECTIVES:
- To estimate the time to progression and overall survival measured from the date of CED.
II. To determine the objective tumor response rate, based upon MR imaging, every 8 weeks for first year and then every 12 weeks.
III. To evaluate the possible effect on tumor histology, as assessed by comparing pre-treatment tumor samples to post-treatment tumor samples in patients who undergo subsequent repeat surgical procedures for progression after being treated as part of this protocol.
IV. Pharmacokinetics measurements will also be taken at pre-dose, 1 day after the drug is administered, and 1 week post-op.
OUTLINE:
Participants will be enrolled in a 3+3 dose escalation model with a two cohort concentration escalation, enrolling at least 3 patients in each cohort which results in each total dose personalized for each participant as all participants will have different size and morphology of tumors requiring different volumes of study infusions ranging from 3 mL for smallest tumor to approximately 17 mL for largest tumor (4 cm). Enrollment into a subsequent cohort will not start until after 30 days after monitoring all patients in cohort prior. Participants will be followed for 12 months from CED procedure or until death or institution of alternate anti-neoplastic therapy for progressive recurrent HGG.
- Conditions
- High Grade Glioma
- Being tested
- nanoliposomal irinotecan
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoliposomal irinotecanDrug
Also called MM-398, ONIVYDE
The drug named here (nanoliposomal irinotecan) will be used in varying amounts, based on tumor volume.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 20 mg | Experimental | Tumor diameter: 1 cm, Tumor volume: ~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 20 mg/ml, Infusion time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 2 - 40 mg | Experimental | Tumor diameter: 2 cm,Tumor volume: ~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 3 - 140 mg | Experimental | Tumor diameter: 3 cm, Tumor volume: ~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 140 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 4 - 340 mg | Experimental | Tumor diameter: 4 cm, Tumor volume: ~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 340 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 5 - 40 mg | Experimental | Tumor diameter: 1 cm, Tumor volume: ~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 6 - 80 mg | Experimental | Tumor diameter: 2 cm, Tumor volume: ~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 80 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 7 - 280 mg | Experimental | Tumor diameter: 3 cm, Tumor volume: ~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 280 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
| Group 8 - 680 mg | Experimental | Tumor diameter: 4 cm, Tumor volume: ~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 680 mg/ml, Infusion Time: 6-24 hours, no more than 48 Receives: Drug: nanoliposomal irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Dose limiting toxicity (DLT) will be defined as any grade-3 or higher neurological toxicity felt to be attributable to the CED infusion of liposomal-irinotecan with gadolinium, as well as any systemic grade-3 or higher hematologic or non-hematologic toxicity (after maximal medical management of nausea/vomiting/diarrhea), over a period of 30 days after CED infusion.
Measured: 30 days post-infusion
Secondary outcomes (5)
Progression-Free Survival (PFS) at 6 months
Number of patients not having objective progression or death at 6 months after the time from date of study enrollment estimated from the PFS distribution. For patients who are not known to have died or progressed as of the data-inclusion cut-off date, PFS time will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS will be summarized using Kaplan Meier methods and displayed graphically. The median event time and two-sided 95% confidence interval for the median will be reported.
Measured: Up to 6 months
Progression-Free Survival (PFS)
The time from the date of study enrollment to the date of first observation of objective progression or death from any cause, whichever occurs first. For patients who are not known to have died or progressed as of the data-inclusion cut-off date, PFS time will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS will be summarized using Kaplan Meier methods and displayed graphically. The median event time and two-sided 95% confidence interval for the median will be reported.
Measured: Up to 10 years
Overall Survival at 12 months
The time from the date of study enrollment to the date of death from any cause. For patients who are not known to have died as of the 12 month cut-off date, survival time will be censored at the date of the last known survival status of participant prior to the date of any subsequent systematic anticancer therapy. OS will be summarized using Kaplan Meier methods and displayed graphically. The median event time and two-sided 95% confidence interval for the median will be reported.
Measured: Up to 12 months
Overall Survival (OS)
The time from the date of study enrollment to the date of death from any cause. For patients who are not known to have died as of the data-inclusion cut-off date, survival time will be censored at the date of the last known survival status of participant prior to the date of any subsequent systematic anticancer therapy. OS will be summarized using Kaplan Meier methods and displayed graphically. The median event time and two-sided 95% confidence interval for the median will be reported.
Measured: Up to 10 years
Objective Tumor Response Rate
Overall response rate (ORR) is the proportion of patients who achieved a complete response (CR) or partial response (PR) out of all randomly assigned patients. Based on Response assessment in neuro-oncology criteria (RANO), a responder is defined by radiographic and clinical criteria. Complete response or PR will be first assessed by radiographic changes as determined by an improvement of the bi-dimensional evaluation of the tumor size. In addition, changes in neurologic function and steroid use will be considered to determine stable disease (SD). The objective response rate (ORR) will be summarized with the corresponding exact two-sided 95% confidence interval calculated using a method based on the F distribution
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start23 Oct 2014
- Primary completion31 Dec 2020
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Nicholas Butowski, University of California, San Francisco
- Investigators
- Nicholas Butowski, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022644
- Sponsor's protocol ID
- Nano CED
- Other IDs
- 13-12025, 5R21CA186140-02, NCI-2017-01304, 13108
- Status last verified
- Jun 2023
- First submitted
- 11 Dec 2013
- Last updated
- 29 Jun 2023
- 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Convection-Enhanced Delivery of Liposomal-Irinotecan Using Real-Time Imaging With Gadolinium In Patients With Recurrent High Grade Glioma
- ClinicalTrials.gov ID
- NCT02022644
- Acronym / sponsor ID
- Nano CED
- Conditions
- High Grade Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Ipsen, National Cancer Institute (NCI)
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Dec 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 single center, dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery (CED).
Detailed description
PRIMARY OBJECTIVE:
- To determine the safety and tolerability of liposomal-irinotecan with gadolinium given by intra tumoral real-time convection enhanced delivery in patients with recurrent high grade glioma (HGG).
SECONDARY OBJECTIVES:
- To optimize the magnetic resonance image-guided intracranial injection procedure in patients with recurrent HGG by correlating the observed distribution of gadolinium to pre-treatment modeling of the drug distribution utilizing predictive imaging software.
EXPLORATORY OBJECTIVES:
- To estimate the time to progression and overall survival measured from the date of CED.
II. To determine the objective tumor response rate, based upon MR imaging, every 8 weeks for first year and then every 12 weeks.
III. To evaluate the possible effect on tumor histology, as assessed by comparing pre-treatment tumor samples to post-treatment tumor samples in patients who undergo subsequent repeat surgical procedures for progression after being treated as part of this protocol.
IV. Pharmacokinetics measurements will also be taken at pre-dose, 1 day after the drug is administered, and 1 week post-op.
OUTLINE:
Participants will be enrolled in a 3+3 dose escalation model with a two cohort concentration escalation, enrolling at least 3 patients in each cohort which results in each total dose personalized for each participant as all participants will have different size and morphology of tumors requiring different volumes of study infusions ranging from 3 mL for smallest tumor to approximately 17 mL for largest tumor (4 cm). Enrollment into a subsequent cohort will not start until after 30 days after monitoring all patients in cohort prior. Participants will be followed for 12 months from CED procedure or until death or institution of alternate anti-neoplastic therapy for progressive recurrent HGG.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 20 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 1 cm, Tumor volume: ~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 20 mg/ml, Infusion time: 6-24 hours, no more than 48 |
| Group 2 - 40 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 2 cm,Tumor volume: ~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
| Group 3 - 140 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 3 cm, Tumor volume: ~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 140 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
| Group 4 - 340 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 4 cm, Tumor volume: ~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 340 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
| Group 5 - 40 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 1 cm, Tumor volume: ~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
| Group 6 - 80 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 2 cm, Tumor volume: ~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 80 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
| Group 7 - 280 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 3 cm, Tumor volume: ~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 280 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
| Group 8 - 680 mg | Experimental | Drug: nanoliposomal irinotecanTumor diameter: 4 cm, Tumor volume: ~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 680 mg/ml, Infusion Time: 6-24 hours, no more than 48 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Patients with radiographically proven recurrent, intracranial high grade glioma will be eligible for this protocol. Patients must have evidence of tumor progression as determined by the Revised Assessment in Neuro-Oncology RANO criteria following standard therapy.
- Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a high grade glioma is made.
- There is no limit as to the number of prior treatments but patients must have radiographic evidence of progressive disease
- Recurrent tumor must be a solid, single, supratentorial, contrast-enhancing HGG which have a tumor diameter no larger than 4cm or volume of 34cm3
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Key exclusion criteria (9 listed)
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- HIV-positive patients on combination antiretroviral therapy are ineligible.
- Contrast-enhancing tumor which crosses the midline.
- Multi-focal disease.
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 |
|---|---|---|
| nanoliposomal irinotecanAlso: MM-398, ONIVYDEThe drug named here (nanoliposomal irinotecan) will be used in varying amounts, based on tumor volume. | Drug | Group 1 - 20 mg, Group 2 - 40 mg, Group 3 - 140 mg, Group 4 - 340 mg, Group 5 - 40 mg, Group 6 - 80 mg, Group 7 - 280 mg, Group 8 - 680 mg |
Primary outcome
Maximum tolerated dose
Time frame: 30 days post-infusion
Dose limiting toxicity (DLT) will be defined as any grade-3 or higher neurological toxicity felt to be attributable to the CED infusion of liposomal-irinotecan with gadolinium, as well as any systemic grade-3 or higher hematologic or non-hematologic toxicity (after maximal medical management of nausea/vomiting/diarrhea), over a period of 30 days after CED infusion.
5 secondary outcomes
Progression-Free Survival (PFS) at 6 months
Time frame: Up to 6 months
Progression-Free Survival (PFS)
Time frame: Up to 10 years
Overall Survival at 12 months
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 10 years
Objective Tumor Response Rate
Time frame: Up to 10 years
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 29 Jun 2023.
- 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.
Nicholas Butowski, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nanoliposomal irinotecan in people with High Grade Glioma, run by University of California, San Francisco at 1 site 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 31 inclusion and 9 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Maximum tolerated dose (time frame: 30 days post-infusion). 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 Jun 2023.