Breast CancerPhase 1NCT01761240
Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
A Phase 1 study testing MORAb-066 in people with Breast Cancer and Pancreatic Cancer, run by Morphotek at 2 sites in United States.
Trial summary
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer
- What is being tested?
- MORAb-066
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2013to 9 Feb 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following criteria in order to be included in this clinical trial:
- Histologically or cytologically confirmed diagnosis of breast, colorectal, pancreas, or NSCLC (adenocarcinoma) that is metastatic or unresectable for which there is no effective therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 (see Appendix A).
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Subject has recovered (to Grade less than or equal to 1) from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions (described separately below).
- Adequate organ system function less than or equal to 2 weeks prior to Day1, defined as follows:
Show all 18Show fewer
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
- Platelets greater than or equal to 100 x 10^9/L
- Hemoglobin greater than or equal to 9 g/dL
- Prothrombin time/partial thromboplastin time (PT/PTT) within institutional limits of normal
- Serum total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 x ULN if no liver involvement or less than or equal to 5 x ULN with liver involvement.
- Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 mL/min as calculated by the Cockcroft-Gault method, OR 24-hour measured urine creatinine clearance greater than or equal to 50 mL/min.
- Life expectancy of greater than or equal to 12 weeks.
- Female patients of child-bearing potential (see Appendix C), and all male patients must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after their last MORAb-066 administration. A barrier method of contraception must be included.
- Patients must be greater than or equal to 18 years of age.
- Patients entering this study will be asked to provide archival tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, the subject will still be eligible for enrollment into the study.
- Ability to understand the nature of this study and give written informed consent.
Who cannot join
- Patients who meet any of the following criteria will be excluded from trial entry:
- Patients currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
- Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of MORAb-066. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of MORAb-066 is required.
- Any major surgery, chemotherapy, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed greater than or equal to 2 weeks).
- Subject has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) less than or equal to 28 days or limited field radiation for palliation less than or equal to 14 days prior to starting study drug or has not recovered from side effects of such therapy.
- Known intracranial involvement, leptomeningeal metastases or spinal cord compression due to disease.
Show all 29Show fewer
- Known allergy or hypersensitivity to monoclonal antibodies.
- Known bleeding diathesis, such as factor deficiency, factor inhibitor, platelet disorder, or who are on active anticoagulation, or any dose of aspirin within 5 days prior to first dose of MORAb-066.
- Known prior significant bleeding history.
- Patients with ureteral stents or 3+ blood in the urine at baseline.
- Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
- Patients who received a previous mAb therapy and have evidence of an immune or allergic reaction or previously documented HAHA reaction.
- A serious non-healing wound, active ulcer, or untreated bone fracture. An abdominal fistula or gastrointestinal perforation less than 6 months prior to treatment.
- History of hematemesis or hemoptysis (defined as having bright red blood of 1/2 teaspoon or more per episode) less than or equal to 1 month prior to study enrollment.
- Subject has cardiac dysfunction including any of the following:
- Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction function
- QTcF greater than 470 msec
- History of documented congestive heart failure (New York Heart Association functional classification III-IV [see Appendix B])
- Angina not well-controlled by medication
- A serious active infection (bacterial or fungal) at the time of treatment, or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment.
- Chronic inflammatory disorder(e.g., inflammatory bowel disease, active vasculitis).
- Herbal preparations/medications must be discontinued 7 days prior to first dose of study drug (see Section 5.3.1).
- Known diagnosis of human immunodeficiency virus, Hepatitis B or Hepatitis C.
- History or current diagnosis of glomerulonephritis
- History of clinically significant or current diagnosis of hematuria.
- Women who are pregnant or lactating.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
- Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Nashville, Tennessee
Study site
Oklahoma City, Oklahoma
About this study
Official title: A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-066, a Humanized Monoclonal Antibody to Human Tissue Factor, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or Non-Small Cell Lung Cancer (Adenocarcinoma) Malignancies
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify the maximum tolerated dose (MTD) when MORAb-066 is administered IV once weekly on a 28-day cycle.
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Being tested
- MORAb-066
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-066Drug
MORAb-066 infusion.
| Study group | Role | What they receive |
|---|---|---|
| MORAb-066 0.1 mg/kg | Experimental | Participants will receive MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. Receives: Drug: MORAb-066 |
| MORAb-066 0.3 mg/kg | Experimental | Participants will receive MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. Receives: Drug: MORAb-066 |
| MORAb-066 1 mg/kg | Experimental | Participants will receive MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. Receives: Drug: MORAb-066 |
| MORAb-066 2 mg/kg | Experimental | Participants will receive MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. Receives: Drug: MORAb-066 |
| MORAb-066 3 mg/kg | Experimental | Participants will receive MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. Receives: Drug: MORAb-066 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.
Measured: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Secondary outcomes (11)
Number of Participants With Dose Limiting Toxicity (DLT)
DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.
Measured: Cycle 1 (Cycle length=28 days)
Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.
Measured: Cycle 1 (Cycle length=28 days)
Cmax: Maximum Observed Serum Concentration for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
t1/2: Terminal Elimination Phase Half-Life for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Vd: Volume of Distribution for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
CL: Total Body Clearance for MORAb-066
Measured: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Number of Participants With Best Overall Response (BOR)
BOR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target and non-target lesions is complete response (CR) or partial response (PR). CR: disappearance of target and non-target lesions, normalization of tumor marker level, all lymph nodes must be non-pathological in size (less than 10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Measured: Up to approximately 2 years 7 months
Number of Participants Positive for Antidrug Antibodies (ADA)
Measured: Up to approximately 2 years 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study start19 Jun 2013
- Primary completion9 Feb 2016
- Study completion9 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761240
- Sponsor's protocol ID
- MORAb-066-001
- Status last verified
- Feb 2017
- First submitted
- 3 Jan 2013
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-066, a Humanized Monoclonal Antibody to Human Tissue Factor, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or Non-Small Cell Lung Cancer (Adenocarcinoma) Malignancies
- ClinicalTrials.gov ID
- NCT01761240
- Acronym / sponsor ID
- MORAb-066-001
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- 19 Jun 2013 (actual)
- Primary completion
- 9 Feb 2016 (actual)
- Study completion
- 9 Feb 2016 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify the maximum tolerated dose (MTD) when MORAb-066 is administered IV once weekly on a 28-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MORAb-066 0.1 mg/kg | Experimental | Drug: MORAb-066Participants will receive MORAb-066 0.1 milligram per kilogram (mg/kg), infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| MORAb-066 0.3 mg/kg | Experimental | Drug: MORAb-066Participants will receive MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| MORAb-066 1 mg/kg | Experimental | Drug: MORAb-066Participants will receive MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| MORAb-066 2 mg/kg | Experimental | Drug: MORAb-066Participants will receive MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
| MORAb-066 3 mg/kg | Experimental | Drug: MORAb-066Participants will receive MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed diagnosis of breast, colorectal, pancreas, or NSCLC (adenocarcinoma) that is metastatic or unresectable for which there is no effective therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 (see Appendix A).
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Subject has recovered (to Grade less than or equal to 1) from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions (described separately below).
- Adequate organ system function less than or equal to 2 weeks prior to Day1, defined as follows:
Key exclusion criteria (29 listed)
- Patients currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
- Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of MORAb-066. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of MORAb-066 is required.
- Any major surgery, chemotherapy, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed greater than or equal to 2 weeks).
- Subject has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) less than or equal to 28 days or limited field radiation for palliation less than or equal to 14 days prior to starting study drug or has not recovered from side effects of such therapy.
- Known intracranial involvement, leptomeningeal metastases or spinal cord compression due to 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 |
|---|---|---|
| MORAb-066MORAb-066 infusion. | Drug | MORAb-066 0.1 mg/kg, MORAb-066 0.3 mg/kg, MORAb-066 1 mg/kg, MORAb-066 2 mg/kg, MORAb-066 3 mg/kg |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations.
11 secondary outcomes
Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Cycle 1 (Cycle length=28 days)
Maximum Tolerated Dose (MTD)
Time frame: Cycle 1 (Cycle length=28 days)
Cmax: Maximum Observed Serum Concentration for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
t1/2: Terminal Elimination Phase Half-Life for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Vd: Volume of Distribution for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
CL: Total Body Clearance for MORAb-066
Time frame: Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Number of Participants With Best Overall Response (BOR)
Time frame: Up to approximately 2 years 7 months
Number of Participants Positive for Antidrug Antibodies (ADA)
Time frame: Up to approximately 2 years 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 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 MORAb-066 in people with Breast Cancer and Pancreatic Cancer, run by Morphotek at 2 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 18 inclusion and 29 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.