GlioblastomaPhase 1G-FORCE-1NCT02871843
RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas
A Phase 1 study testing RRx-001 dose escalation with TMZ + RT, Radiation and Fixed dose Temozolomide (75 mg/m2) in people with Glioblastoma and Oligodendroglioma, run by EpicentRx, Inc. at 3 sites in United States.
Trial summary
This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By "add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or "added on" to standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Oligodendroglioma, Anaplastic Oligodendroglioma
- What is being tested?
- RRx-001 dose escalation with TMZ + RT, Radiation and Fixed dose Temozolomide (75 mg/m2)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2017to 19 Sep 2021
- 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
- Histologically proven diagnosis of high-grade glioma, including anaplastic glioma (WHO grade III with 1p/19q chromosomes intact), glioblastoma (WHO grade IV) or gliosarcoma (WHO Grade IV);
- The tumor must not have an infratentorial component;
- The patient must have recovered from the effects of surgery, postoperative infection and other complications before enrollment;
- Estimated survival of at least 12 weeks;
- Karnofsky Performance Score of ≥ 70% at the time of entry
- Stable or decreasing steroid dose within 2 weeks of first dose of study drug if patient is taking steroids. No steroid use is also acceptable.
Show all 11Show fewer
- Neurological stability for at least 14 days prior to first dose of study drug;
- Acceptable liver function at Screening,
- Serum creatinine < 1.5x institution upper limit of normal
- Acceptable hematologic status at Screening
- Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception.
Who cannot join
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
- Recurrent malignant gliomas previously treated with radiotherapy and/or chemotherapy
- Metastases detected below the tentorium or beyond the cranial vault, including tumors with evidence of leptomeningeal metastases as previously indicated;
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted;
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), that would result in overlap of radiation fields.
- Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity;
Show all 12Show fewer
- Unresolved toxicity higher than CTCAE (v. 4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia and hypothyroidism;
- Acquired immune deficiency syndrome (AIDS) due to the potential for increased complications from treatment; note, however, that HIV testing is not required
- No other concurrent chemotherapeutic or investigational agents for this cancer. However, concurrent glucocorticoids are allowed;
- Inability to swallow pills;
- Serious co-morbid medical conditions, or a clinically significant laboratory finding(s) or any finding(s) on history and/or examination that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk;
- Patients who are pregnant or lactating or who are planning to become pregnant during the course of the study are excluded.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Cancer Institute of New Jersey (Rutgers University)
New Brunswick, New Jersey, 08903
Weill Cornell Brain Tumor Center
New York, New York, 10021
University of California San Francisco (UCSF)
San Francisco, California, 94143
About this study
Official title: G-FORCE-1: An Open-Label Phase 1 Two Part Dose Escalation Trial of RRx-001 Concurrent With Radiation and Temozolomide and RRx-001 + Temozolomide Post-RT In Newly Diagnosed Glioblastoma and Anaplastic Gliomas With Intact 1p/19q Chromosomes
This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By "add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or "added on" to standard of care. In newly diagnosed GBM standard of care consists of radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by maintenance TMZ given until the tumor progresses or worsens. By "maintenance" therapy what is meant is that TMZ is given less frequently to prolong or extend the time during which the tumor remains stable.
G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation, Part A) patients will be entered or assigned sequentially (that is consecutively) to gradually escalating or increasing doses of RRx-001 after patients have been entered on the previous dose until such time as it is no longer tolerated. At each dose level, a separate cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be administered by intravenous infusion (in other words, by slow injection in the veins) over 30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer.
Read more
In the second part of this study (Part B), new groups or cohorts of patients will receive RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will receive increasing doses of RRx-001 and temozolomide (in other words, a double dose escalation) to establish an acceptable safety and activity window, in other words, a dose range that is relatively free of toxicity as well as active against the tumor, although the primary purpose of this study is to assess or evaluate safety.
The reason or rationale to "add on" RRx-001 to radiotherapy and TMZ, which is described in more detail below on this page, is as follows: RRx-001 is a radiosensitizer and a chemosensitizer, which means that experimentally it increases the activity of radiation and chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have experienced minimal toxicity or side effects with RRx-001 alone and also in combination with radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well with radiotherapy and TMZ in GBM without adding toxicity
Read the detailed description
Glioblastoma multiforme also known by the feared three letter acronym or abbreviation, GBM, is the most common, aggressive and deadly type of brain tumor, which is standardly treated with a combination of radiation and temozolomide (TMZ), an FDA approved chemotherapy agent, followed by temozolomide alone. One of the reasons why glioblastoma is so aggressive and deadly has to do with poor blood flow: it turns out that GBM has multiple inefficient and leaky blood vessels, which leads to ineffective and irregular delivery of nutrients and oxygen to the tumor.
As illogical as it may sound at first, depriving cancer cells of the oxygen and vital nutrients that they need to grow actually makes them more (not less as might be expected) aggressive and harder to treat.
Here's why: for radiation to have an effect on the tumor oxygen is required since the combination of oxygen and radiation produces unstable and highly reactive free radicals; these microscopic free radicals are the equivalent of a spray of bullets, which ricochet or bounce around violently inside the tumor producing catastrophic damage.
Likewise, for chemotherapy such as TMZ to work it has to reach the tumor and when blood vessels are so abnormal that the blood practically ceases to flow the TMZ, for example, may either never actually get there or may arrive in such small quantities that it is ineffective.
The expression "survival of the fittest" also applies: under the poorly oxygenated harsh conditions, which result from this sluggish blood flow only the toughest and most resistant cancer cells survive, making the tumor that much harder to eliminate with traditional therapies.
Think of the blood flow to the tumor as a swamp or a marsh where the rotten water seeps and pools rather than flows and where only the hardiest organisms can compete for scarce resources and low oxygen, which partly explains why this GBM tumor type in particular is often so hard to treat.
This clinical trial, called G-FORCE-1, tests the safety, tolerability and activity of RRx-001, an experimental anticancer agent, with standard radiation and temozolomide followed by temozolomide + RRx-001 in newly diagnosed GBM. Evidence in animals and in human patients with brain metastases, that is cancer cells, which have metastasized or spread to the brain from different locations in the body, has shown that RRx-001, which has many anticancer mechanisms and is generally very well tolerated both alone and in combination with radiation in other clinical trials, increases blood flow to tumors.
The increased blood flow has three possible beneficial consequences: 1) more oxygen is delivered to the tumor, which has the potential to increase the activity of radiation 2) more TMZ makes it to the tumor, which has the potential to increase the activity of TMZ and 3) as conditions in the tumor gradually improve from intolerable or barely tolerable to more acceptable, treatment sensitive cancer cells may start to reappear.
RRx-001 is also thought to work by stimulating the immune system to attack the tumor; tumor biopsies or samples from patients in other RRx-001 trials have demonstrated the infiltration or penetration of a particular kind of white cell called T-cells. As a fourth potentially beneficial consequence of the increased blood flow from RRx-001, these immune T-cells may have better access to the tumor, which may, in turn, increase killing of the cancer cells.
G-FORCE-1 is a Phase 1 trial, which means that the main endpoint is to test the safety and tolerability of RRx-001 in combination with radiation and temozolomide and not its activity; however patients will be followed for responses to treatment and overall survival
- Being tested
- RRx-001 dose escalation with TMZ + RT, Radiation, Fixed dose Temozolomide (75 mg/m2), TMZ Maintenance
- Medical subject headings
- Glioblastoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRx-001 dose escalation with TMZ + RTDrug
Dose escalation of RRx-001. Dose levels of 0.5, 1.0, 2.0 and 4.0 mg, once weekly.
RadiationRadiation
Conformal or intensity-modulated radiotherapy (60 Gy in 2 Gy fractions) given 5 days a week for 30 fractions (about 6 weeks)
Fixed dose Temozolomide (75 mg/m2)Drug
Also called TMZ
Oral temozolomide 75 mg/m2 daily for 6 weeks
TMZ MaintenanceDrug
TMZ maintenance at 150-200 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Escalation of RRx-001 with TMZ + RT | Experimental | Dose escalation of RRx-001 with fixed doses of Temozolomide and radiation followed by Temozolomide maintenance therapy Receives: Drug: RRx-001 dose escalation with TMZ + RT; Radiation: Radiation; Drug: Fixed dose Temozolomide (75 mg/m2); Drug: TMZ Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, frequency and type of adverse events
Measured: 12 weeks
Secondary outcomes (4)
Objective Response Rate (ORR)
Objective Response rate as determined by the patient's best tumor response, Duration Of Response (DOR) and Time To Progression (TTP) using modified RANO criteria
Measured: 4 months
Clinical Benefit Rate (CBR)
Clinical Benefit Rate as determined by the patient's best tumor response, Duration Of Response (DOR) and Time To Progression (TTP) using modified RANO criteria
Measured: 4 months
Intracranial Progression Free Survival
Intracranial PFS is defined as the time that a patient lives with intracranial tumors before progression. Changes in intracranial tumors will be measured by MRI and scored using RANO criteria. The response assessment will take into account MacDonald Criteria using bi-dimensional measurements of the largest contrast- enhancing area, RANO Criteria, FLAIR imaging and clinical status.
Measured: 4 months
Overall Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start14 Feb 2017
- Primary completion11 Oct 2019
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 Dose Escalation
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Oronsky, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871843
- Sponsor's protocol ID
- RRx001-17-02
- Acronym
- G-FORCE-1
- Status last verified
- May 2022
- First submitted
- 11 Aug 2016
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-FORCE-1: An Open-Label Phase 1 Two Part Dose Escalation Trial of RRx-001 Concurrent With Radiation and Temozolomide and RRx-001 + Temozolomide Post-RT In Newly Diagnosed Glioblastoma and Anaplastic Gliomas With Intact 1p/19q Chromosomes
- ClinicalTrials.gov ID
- NCT02871843
- Acronym / sponsor ID
- G-FORCE-1 / RRx001-17-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 18 Aug 2016 (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 two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By "add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or "added on" to standard of care. In newly diagnosed GBM standard of care consists of radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by maintenance TMZ given until the tumor progresses or worsens. By "maintenance" therapy what is meant is that TMZ is given less frequently to prolong or extend the time during which the tumor remains stable.
G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation, Part A) patients will be entered or assigned sequentially (that is consecutively) to gradually escalating or increasing doses of RRx-001 after patients have been entered on the previous dose until such time as it is no longer tolerated. At each dose level, a separate cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be administered by intravenous infusion (in other words, by slow injection in the veins) over 30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer.
In the second part of this study (Part B), new groups or cohorts of patients will receive RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will receive increasing doses of RRx-001 and temozolomide (in other words, a double dose escalation) to establish an acceptable safety and activity window, in other words, a dose range that is relatively free of toxicity as well as active against the tumor, although the primary purpose of this study is to assess or evaluate safety.
The reason or rationale to "add on" RRx-001 to radiotherapy and TMZ, which is described in more detail below on this page, is as follows: RRx-001 is a radiosensitizer and a chemosensitizer, which means that experimentally it increases the activity of radiation and chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have experienced minimal toxicity or side effects with RRx-001 alone and also in combination with radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well with radiotherapy and TMZ in GBM without adding toxicity
Detailed description
Glioblastoma multiforme also known by the feared three letter acronym or abbreviation, GBM, is the most common, aggressive and deadly type of brain tumor, which is standardly treated with a combination of radiation and temozolomide (TMZ), an FDA approved chemotherapy agent, followed by temozolomide alone. One of the reasons why glioblastoma is so aggressive and deadly has to do with poor blood flow: it turns out that GBM has multiple inefficient and leaky blood vessels, which leads to ineffective and irregular delivery of nutrients and oxygen to the tumor.
As illogical as it may sound at first, depriving cancer cells of the oxygen and vital nutrients that they need to grow actually makes them more (not less as might be expected) aggressive and harder to treat.
Here's why: for radiation to have an effect on the tumor oxygen is required since the combination of oxygen and radiation produces unstable and highly reactive free radicals; these microscopic free radicals are the equivalent of a spray of bullets, which ricochet or bounce around violently inside the tumor producing catastrophic damage.
Likewise, for chemotherapy such as TMZ to work it has to reach the tumor and when blood vessels are so abnormal that the blood practically ceases to flow the TMZ, for example, may either never actually get there or may arrive in such small quantities that it is ineffective.
The expression "survival of the fittest" also applies: under the poorly oxygenated harsh conditions, which result from this sluggish blood flow only the toughest and most resistant cancer cells survive, making the tumor that much harder to eliminate with traditional therapies.
Think of the blood flow to the tumor as a swamp or a marsh where the rotten water seeps and pools rather than flows and where only the hardiest organisms can compete for scarce resources and low oxygen, which partly explains why this GBM tumor type in particular is often so hard to treat.
This clinical trial, called G-FORCE-1, tests the safety, tolerability and activity of RRx-001, an experimental anticancer agent, with standard radiation and temozolomide followed by temozolomide + RRx-001 in newly diagnosed GBM. Evidence in animals and in human patients with brain metastases, that is cancer cells, which have metastasized or spread to the brain from different locations in the body, has shown that RRx-001, which has many anticancer mechanisms and is generally very well tolerated both alone and in combination with radiation in other clinical trials, increases blood flow to tumors.
The increased blood flow has three possible beneficial consequences: 1) more oxygen is delivered to the tumor, which has the potential to increase the activity of radiation 2) more TMZ makes it to the tumor, which has the potential to increase the activity of TMZ and 3) as conditions in the tumor gradually improve from intolerable or barely tolerable to more acceptable, treatment sensitive cancer cells may start to reappear.
RRx-001 is also thought to work by stimulating the immune system to attack the tumor; tumor biopsies or samples from patients in other RRx-001 trials have demonstrated the infiltration or penetration of a particular kind of white cell called T-cells. As a fourth potentially beneficial consequence of the increased blood flow from RRx-001, these immune T-cells may have better access to the tumor, which may, in turn, increase killing of the cancer cells.
G-FORCE-1 is a Phase 1 trial, which means that the main endpoint is to test the safety and tolerability of RRx-001 in combination with radiation and temozolomide and not its activity; however patients will be followed for responses to treatment and overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Escalation of RRx-001 with TMZ + RT | Experimental | Drug: RRx-001 dose escalation with TMZ + RT, Radiation: Radiation, Drug: Fixed dose Temozolomide (75 mg/m2), Drug: TMZ MaintenanceDose escalation of RRx-001 with fixed doses of Temozolomide and radiation followed by Temozolomide maintenance therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven diagnosis of high-grade glioma, including anaplastic glioma (WHO grade III with 1p/19q chromosomes intact), glioblastoma (WHO grade IV) or gliosarcoma (WHO Grade IV);
- The tumor must not have an infratentorial component;
- The patient must have recovered from the effects of surgery, postoperative infection and other complications before enrollment;
- Estimated survival of at least 12 weeks;
- Karnofsky Performance Score of ≥ 70% at the time of entry
Key exclusion criteria (12 listed)
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
- Recurrent malignant gliomas previously treated with radiotherapy and/or chemotherapy
- Metastases detected below the tentorium or beyond the cranial vault, including tumors with evidence of leptomeningeal metastases as previously indicated;
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted;
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), that would result in overlap of radiation fields.
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 |
|---|---|---|
| RRx-001 dose escalation with TMZ + RTDose escalation of RRx-001. Dose levels of 0.5, 1.0, 2.0 and 4.0 mg, once weekly. | Drug | Escalation of RRx-001 with TMZ + RT |
| RadiationConformal or intensity-modulated radiotherapy (60 Gy in 2 Gy fractions) given 5 days a week for 30 fractions (about 6 weeks) | Radiation | Escalation of RRx-001 with TMZ + RT |
| Fixed dose Temozolomide (75 mg/m2)Also: TMZOral temozolomide 75 mg/m2 daily for 6 weeks | Drug | Escalation of RRx-001 with TMZ + RT |
| TMZ MaintenanceTMZ maintenance at 150-200 mg/m2 | Drug | Escalation of RRx-001 with TMZ + RT |
Primary outcome
Number, frequency and type of adverse events
Time frame: 12 weeks
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 4 months
Clinical Benefit Rate (CBR)
Time frame: 4 months
Intracranial Progression Free Survival
Time frame: 4 months
Overall Survival
Time frame: 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 16 May 2022.
Related trials for Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
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.
Bryan Oronsky study director
Chief Medical Officer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RRx-001 dose escalation with TMZ + RT, Radiation and Fixed dose Temozolomide (75 mg/m2) in people with Glioblastoma and Oligodendroglioma, run by EpicentRx, Inc. at 3 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 11 inclusion and 12 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 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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, frequency and type of adverse events (time frame: 12 weeks). 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 16 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.