Chronic Lymphocytic LeukemiaPhase 1NCT01644253
Phase 1b Safety and Efficacy Study of TRU-016
A Phase 1 study testing 20 mg/kg TRU-016 + Rituximab, 10 mg/kg TRU-016 + Rituximab and TRU-016 20 mg/kg + Obinutuzumab in people with Chronic Lymphocytic Leukemia and Peripheral T-cell Lymphoma, run by Aptevo Therapeutics at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Peripheral T-cell Lymphoma
- What is being tested?
- 20 mg/kg TRU-016 + Rituximab, 10 mg/kg TRU-016 + Rituximab and TRU-016 20 mg/kg + Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2012to 21 Apr 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
- Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk CLL. Cohort 8 patients must have a diagnosis of PTCL.
- No prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments. For Cohort 5, patients must have failed to respond or relapsed after 1 or more treatment regimens. For Cohort 6, patients who have been receiving ibrutinib for at least 12 months, have not had a CR, and in whom no cysteine 481 mutation is detected. For Cohort 7, patients who are receiving ibrutinib with stable disease and now have the cysteine 481 mutant clone present at levels of >1%. For Cohort 8, have refractory or relapsed PTCL after one or more prior therapies.
- At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a 2-month period or an unanticipated doubling time of less than 6 months
- For Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
- Age >/= to 18 years
- ECOG performance status of </= 2
Show all 10Show fewer
- Life expectancy > 6 months in opinion of Investigator
- Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
- ANC >/= 800/mm3, Cohort 8 (PTCL): ANC >/= 1000/mm3
- Platelets >/= 30,000/mm3
Who cannot join
- For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL. Cohort 8: Received prior treatment with bendamustine and did not respond during treatment or relapsed less than sex months after completing treatment.
- Has received an investigational therapy within 30 days of first dose of study drug
- Previous or concurrent additional malignancy
- Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease
- Positive serology for HIV or hepatitis C
- Hepatitis B surface antigen or hepatitis B core antibody positive
- Pregnant or breastfeeding
- Known current drug or alcohol abuse
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Augusta, Georgia, 30912
Study site
Columbus, Ohio, 43210
Greenville Health System
Greenville, South Carolina, 29605
Study site
Houston, Texas, 77030
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Swedish Cancer Institute,1221 Madison St.
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.
Read the detailed description
The study will consist of 8 dose cohorts:
- Previously untreated patients 20 mg/kg TRU-016 + rituximab.
- Relapsed patients, 20 mg/kg TRU-016 + rituximab.
- Previously untreated patients 10 mg/kg TRU-016 + rituximab.
- Previously untreated patients TRU-016 + obinutuzumab.
- Relapsed patients, 20 mg/kg TRU-016 + rituximab + idelalisib.
- Patients with CLL on ibrutinib or another BTK inhibitor for a total of more than 1 year who have not had a complete response (CR) will continue receiving ibrutinib or another BTK inhibitor.
- Patients with CLL on ibrutinib or another BTK inhibitor with stable disease and in whom the cysteine 481 mutant clone is present at a level >1%, will continue receiving ibrutinib or the alternative BTK inhibitor.
- Patients with relapsed or refractory PTCL will receive TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days) + bendamustine for 2 days every cycle for 6 cycles.
- Being tested
- 20 mg/kg TRU-016 + Rituximab, 10 mg/kg TRU-016 + Rituximab, TRU-016 20 mg/kg + Obinutuzumab, TRU-016 6-20 mg/kg + idelalisib + rituximab, TRU-016 10-20 mg/kg + ibrutinib
- Keywords
- chronic lymphocytic leukemia, CLL, previously untreated chronic lymphocytic leukemia, peripheral T-cell lymphoma, PTCL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg/kg TRU-016 + RituximabBiological
Also called Rituxan
TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses
Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses
10 mg/kg TRU-016 + RituximabBiological
Also called Rituxan
TRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses
Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule
TRU-016 20 mg/kg + ObinutuzumabBiological
Also called Gazyva
TRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months
Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months
TRU-016 6-20 mg/kg + idelalisib + rituximabBiological
Also called Zydelig, Rituxan
TRU-016: 6 mg/kg on Days 15-36 weekly, 10 mg/kg on Days 43 and 50, then 20 mg/kg once a month for 5 months.
TRU-016 10-20 mg/kg + ibrutinibBiological
Also called Imbruvica
TRU-016: Dosed weekly for 8 weeks followed by 4 monthly intravenous (IV) infusions. The first dose will be 10 mg/kg and all subsequent doses will be 20 mg/kg.
TRU-016 10-20 mg/kg + bendamustineBiological
TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days). Bendamustine (90 mg/m2 on days 2 and 3 of cycle 1 and then days 1 and 2 of cycles 2 to 6) will be infused after completion of TRU-016. If a patient is benefiting with stable disease or better, then TRU-016 may continue to be dosed every 3 weeks after the first 6 cycles; bendamustine will not be dosed beyond 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Previously Untreated CLL | Experimental | 20 mg/kg TRU-016 + Rituximab Receives: Biological: 20 mg/kg TRU-016 + Rituximab |
| Cohort 2 - Relapsed CLL | Experimental | 20 mg/kg TRU-016 + Rituximab Receives: Biological: 20 mg/kg TRU-016 + Rituximab |
| Cohort 3 - Previously Untreated CLL | Experimental | 10 mg/kg TRU-016 + Rituximab Receives: Biological: 10 mg/kg TRU-016 + Rituximab |
| Cohort 4 - Previously Untreated CLL | Experimental | 20 mg/kg TRU-016 20 + Obinutuzumab Receives: Biological: TRU-016 20 mg/kg + Obinutuzumab |
| Cohort 5 - Relapse CLL | Experimental | 20 mg/kg TRU-016 + idelalisib + rituximab Receives: Biological: TRU-016 6-20 mg/kg + idelalisib + rituximab |
| Cohort 6 - With CLL on ibrutinib with no complete response | Experimental | 20 mg/kg TRU-016 + ibrutinib Receives: Biological: TRU-016 10-20 mg/kg + ibrutinib |
| Cohort 7 - With CLL on ibrutinib with stable disease | Experimental | 20 mg/kg TRU-016 + ibrutinib Receives: Biological: TRU-016 10-20 mg/kg + ibrutinib |
| Cohort 8 - With relapsed or refractory PTCL | Experimental | 20 mg/kg TRU-016 + 90 mg/m2 bendamustine Receives: Biological: TRU-016 10-20 mg/kg + bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: any time point during the study up to 18 months
CLL Cysteine 481 mutation status
The primary endpoint for Cohort 7 is the elimination of the cysteine 481 mutant clone (<1%).
Measured: CLL patients in Cohort 7 will be followed for 9 months unless no cysteine 481 mutation is detected.
Secondary outcomes (11)
Overall Response Rate (ORR)
Measured: any time point during the study up to 18 months
Progression-free survival (PFS)
Measured: any time point during the study up to 18 months
Overall survival (OS)
Measured: any time point during the study up to 18 months
Duration of response (DOR)
Measured: any time point during the study up to 18 months
Resolution of disease-related symptoms
Resolution of disease-related symptoms which are common to the disease include fever, weight loss, night sweats, fatigue, loss of appetite pain, and pruritus; symptoms will be assessed by descriptive statistics and data listings.
Measured: any time point during the study up to 18 months
Maximum serum drug concentration (Cmax)
Measured: any time point during the study up to 12 months
Minimum serum drug concentration (Cmin)
Measured: any time point during the study up to 12 months
Area under the concentration-time curve (AUC0-t and AUC0-∞)
Measured: any time point during the study up to 12 months
Systemic clearance (CL)
Measured: any time point during the study up to 12 months
Volume of distribution (Vd)
Measured: any time point during the study up to 12 months
Elimination half-life (t1/2)
Measured: any time point during the study up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startSep 2012
- Primary completion24 Feb 2020
- Study completion21 Apr 2021
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptevo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott C. Stromatt, M.D., Study director, Aptevo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644253
- Sponsor's protocol ID
- 16009
- Status last verified
- May 2021
- First submitted
- 12 Jul 2012
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01644253
- Acronym / sponsor ID
- 16009
- Keywords
- chronic lymphocytic leukemia, CLL, previously untreated chronic lymphocytic leukemia, peripheral T-cell lymphoma, PTCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Aptevo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 19 Jul 2012 (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.
The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.
Detailed description
The study will consist of 8 dose cohorts:
- Previously untreated patients 20 mg/kg TRU-016 + rituximab.
- Relapsed patients, 20 mg/kg TRU-016 + rituximab.
- Previously untreated patients 10 mg/kg TRU-016 + rituximab.
- Previously untreated patients TRU-016 + obinutuzumab.
- Relapsed patients, 20 mg/kg TRU-016 + rituximab + idelalisib.
- Patients with CLL on ibrutinib or another BTK inhibitor for a total of more than 1 year who have not had a complete response (CR) will continue receiving ibrutinib or another BTK inhibitor.
- Patients with CLL on ibrutinib or another BTK inhibitor with stable disease and in whom the cysteine 481 mutant clone is present at a level >1%, will continue receiving ibrutinib or the alternative BTK inhibitor.
- Patients with relapsed or refractory PTCL will receive TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days) + bendamustine for 2 days every cycle for 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Previously Untreated CLL | Experimental | Biological: 20 mg/kg TRU-016 + Rituximab20 mg/kg TRU-016 + Rituximab |
| Cohort 2 - Relapsed CLL | Experimental | Biological: 20 mg/kg TRU-016 + Rituximab20 mg/kg TRU-016 + Rituximab |
| Cohort 3 - Previously Untreated CLL | Experimental | Biological: 10 mg/kg TRU-016 + Rituximab10 mg/kg TRU-016 + Rituximab |
| Cohort 4 - Previously Untreated CLL | Experimental | Biological: TRU-016 20 mg/kg + Obinutuzumab20 mg/kg TRU-016 20 + Obinutuzumab |
| Cohort 5 - Relapse CLL | Experimental | Biological: TRU-016 6-20 mg/kg + idelalisib + rituximab20 mg/kg TRU-016 + idelalisib + rituximab |
| Cohort 6 - With CLL on ibrutinib with no complete response | Experimental | Biological: TRU-016 10-20 mg/kg + ibrutinib20 mg/kg TRU-016 + ibrutinib |
| Cohort 7 - With CLL on ibrutinib with stable disease | Experimental | Biological: TRU-016 10-20 mg/kg + ibrutinib20 mg/kg TRU-016 + ibrutinib |
| Cohort 8 - With relapsed or refractory PTCL | Experimental | Biological: TRU-016 10-20 mg/kg + bendamustine20 mg/kg TRU-016 + 90 mg/m2 bendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk CLL. Cohort 8 patients must have a diagnosis of PTCL.
- No prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments. For Cohort 5, patients must have failed to respond or relapsed after 1 or more treatment regimens. For Cohort 6, patients who have been receiving ibrutinib for at least 12 months, have not had a CR, and in whom no cysteine 481 mutation is detected. For Cohort 7, patients who are receiving ibrutinib with stable disease and now have the cysteine 481 mutant clone present at levels of >1%. For Cohort 8, have refractory or relapsed PTCL after one or more prior therapies.
- At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a 2-month period or an unanticipated doubling time of less than 6 months
- For Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
- Age >/= to 18 years
Key exclusion criteria (8 listed)
- For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL. Cohort 8: Received prior treatment with bendamustine and did not respond during treatment or relapsed less than sex months after completing treatment.
- Has received an investigational therapy within 30 days of first dose of study drug
- Previous or concurrent additional malignancy
- Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease
- Positive serology for HIV or hepatitis C
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 |
|---|---|---|
| 20 mg/kg TRU-016 + RituximabAlso: RituxanTRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses | Biological | Cohort 1 - Previously Untreated CLL, Cohort 2 - Relapsed CLL |
| 10 mg/kg TRU-016 + RituximabAlso: RituxanTRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule | Biological | Cohort 3 - Previously Untreated CLL |
| TRU-016 20 mg/kg + ObinutuzumabAlso: GazyvaTRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months | Biological | Cohort 4 - Previously Untreated CLL |
| TRU-016 6-20 mg/kg + idelalisib + rituximabAlso: Zydelig, RituxanTRU-016: 6 mg/kg on Days 15-36 weekly, 10 mg/kg on Days 43 and 50, then 20 mg/kg once a month for 5 months. | Biological | Cohort 5 - Relapse CLL |
| TRU-016 10-20 mg/kg + ibrutinibAlso: ImbruvicaTRU-016: Dosed weekly for 8 weeks followed by 4 monthly intravenous (IV) infusions. The first dose will be 10 mg/kg and all subsequent doses will be 20 mg/kg. | Biological | Cohort 6 - With CLL on ibrutinib with no complete response, Cohort 7 - With CLL on ibrutinib with stable disease |
| TRU-016 10-20 mg/kg + bendamustineTRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days). Bendamustine (90 mg/m2 on days 2 and 3 of cycle 1 and then days 1 and 2 of cycles 2 to 6) will be infused after completion of TRU-016. If a patient is benefiting with stable disease or better, then TRU-016 may continue to be dosed every 3 weeks after the first 6 cycles; bendamustine will not be dosed beyond 6 cycles. | Biological | Cohort 8 - With relapsed or refractory PTCL |
Primary outcome
Incidence and severity of adverse events
Time frame: any time point during the study up to 18 months
CLL Cysteine 481 mutation status
Time frame: CLL patients in Cohort 7 will be followed for 9 months unless no cysteine 481 mutation is detected.
The primary endpoint for Cohort 7 is the elimination of the cysteine 481 mutant clone (<1%).
11 secondary outcomes
Overall Response Rate (ORR)
Time frame: any time point during the study up to 18 months
Progression-free survival (PFS)
Time frame: any time point during the study up to 18 months
Overall survival (OS)
Time frame: any time point during the study up to 18 months
Duration of response (DOR)
Time frame: any time point during the study up to 18 months
Resolution of disease-related symptoms
Time frame: any time point during the study up to 18 months
Maximum serum drug concentration (Cmax)
Time frame: any time point during the study up to 12 months
Minimum serum drug concentration (Cmin)
Time frame: any time point during the study up to 12 months
Area under the concentration-time curve (AUC0-t and AUC0-∞)
Time frame: any time point during the study up to 12 months
Systemic clearance (CL)
Time frame: any time point during the study up to 12 months
Volume of distribution (Vd)
Time frame: any time point during the study up to 12 months
Elimination half-life (t1/2)
Time frame: any time point during the study up to 12 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
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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.
Scott C. Stromatt, M.D. study director
Aptevo Therapeutics
8 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 20 mg/kg TRU-016 + Rituximab, 10 mg/kg TRU-016 + Rituximab and TRU-016 20 mg/kg + Obinutuzumab in people with Chronic Lymphocytic Leukemia and Peripheral T-cell Lymphoma, run by Aptevo Therapeutics at 8 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 10 inclusion and 8 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 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: Business decision). 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?
Incidence and severity of adverse events (time frame: any time point during the study up to 18 months). The study lists 2 primary outcomes in all. 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 20 May 2021.