Biliary Tract CarcinomaPhase 2NCT04003896
A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma
A Phase 2 study testing Abemaciclib in people with Biliary Tract Carcinoma, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Carcinoma
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2021to 15 Aug 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 18 years at the time of informed consent.
- Capable and willing to sign informed consent form prior to performing any protocol-related procedures.
- Histologic or cytologic evidence of advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intra-hepatic or extra-hepatic bile ducts), ampullary carcinoma, or gallbladder carcinoma.
- Evidence of recurrent, locally advanced, unresectable, or metastatic disease.
- Progressed following or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician
- Per the opinion of the physician investigator, predicted life expectancy > 3 months.
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- Presence of at least 1 lesion that is measurable or evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
- Per the opinion of the physician investigator, acute toxicities relating to any prior anticancer treatment have improved to Grade 1 or baseline. Exceptions include residual alopecia or Grade 2 peripheral neuropathy.
- Ability to swallow capsules.
- Adequate organ function as evidenced by the laboratory parameters noted in Section 3.0 Study Eligibility.
- Women of childbearing potential (WOCP) defined as not surgically sterile (hysterectomy, tubal ligation, or oophorectomy), or at least 1 year postmenopausal, must have a negative serum pregnancy test before study drug administration on cycle 1 day 1.
- WOCP must use a medically acceptable method of contraception and must agree to continue used of this method for the duration of the study and for 3 weeks after last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method.
- Male, capable of producing offspring, must use a medical acceptable method of contraception and agree to continued use of this method for the duration of the study and for 3 weeks after last dose of study drug because of the possible effects on spermatogenesis. Acceptable methods of contraception include abstinence, WOCP partner's use of barrier method with spermicide, WOCP partner's use of an IUD known to have a failure rate of less than 1% per year, WOCP partner's use of steroidal contraceptive (oral, transdermal, implanted or injected) or WOCP partner is surgically sterile or at least 1 year post-menopausal. In addition, male subjects may not donate sperm for the duration of the study and for 30 days after last dose of study drug.
- Must be willing and able to comply with the protocol, including adhering to study restrictions, remaining at the clinic as required during the study period, and willing to return to the clinic for the follow-up evaluation.
- Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy.
- Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
- Completed last dose of myelosuppressive chemotherapy greater than 21 days prior to first dose of study drug.
- Completed last dose of non-myelosuppressive biological or monoclonal antibody therapy greater than 14 days prior to first dose of study drug.
Who cannot join
- Ongoing or active infection requiring systemic antibiotics.
- Uncontrolled hypertension despite adequate therapy (systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
- Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
- Active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent, and no known active disease in the 3 years prior to enrollment.
- Primary brain tumor or brain metastases from another primary site.
- Known history of human immunodeficiency virus (HIV).
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- Known active viral hepatitis B or viral hepatitis C.
- History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Subjects with controlled atrial fibrillation for more than 30 days are permitted.
- Congestive heart failure (New York Heart Association [NYHA] Class III or IV), or acute coronary syndromes within 6 months of enrollment.
- Female subjects who are pregnant or breastfeeding.
- Any other medical, psychiatric, or social condition, which in the opinion of the physician investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results. For example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy.
- Use of an investigational drug within 1 month before the screening visit or currently participating in another investigational study.
- Any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including extensive gastrointestinal surgery that involves removal of the entire stomach or most of the small intestine or large intestine, bariatric surgery, uncontrolled active Crohn's Disease or ulcerative colitis, or preexisting condition resulting in baseline Grade 2 or higher diarrhea). History of Whipple's procedure is permitted.
- Known hypersensitivity to any of the components in abemaciclib including micro-crystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients-polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min].
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033-0850
About this study
Official title: A Pilot Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
Read the detailed description
Biliary Tract Carcinoma (BTC) is a leading cause of cancer-related mortality. The newly developed small molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), abemaciclib, provides a new opportunity of treating patients with BTC. The goal of this clinical study is to determine the efficacy and safety of abemaciclib in patients with advanced or metastatic BTC that has progressed or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician.
The investigator's objectives for this study are as follows:
Primary Objectives:
- To estimate the objective response rate (ORR)
Secondary Objectives:
- To determine progression free survival (PFS)
- To determine the disease control rate (DCR)
- To determine the overall survival (OS) rate at 6 and 12 months
- To determine quality of life (QoL) using EORTC-QLQ-C30
- Conditions
- Biliary Tract Carcinoma
- Being tested
- Abemaciclib
- Keywords
- Biliary Tract Carcinoma, Abemaciclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called Verzenio
Participant will take 200 mg capsules or tablets orally twice daily. The participant will be instructed to swallow abemaciclib as a whole tablet and not to chew, crush or split capsules or tablets before swallowing. Participants should not ingest abemaciclib tablets if broken, cracked, or otherwise not intact. Doses should be taken at a approximately the same time every day, twice daily. Capsules or tablets can be taken orally with or without food. If the participant vomits or misses a dose of abemaciclib, the participant will be instructed to take the next dose at its scheduled time.
Participants will also be provided with a diary and instructed to keep a twice daily record of the times they have taken their medications and any other events such as vomiting, diarrhea, etc.
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib | Experimental | Abemaciclib will be given as a single oral agent A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death. Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
overall response rate (ORR) is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.The scale of ORR ranges from 0% to 100%, where 0% indicates no subjects achieved CR or PR, and 100% indicates all evaluable subjects achieved CR or PR.
Measured: no longer than 7 months
Secondary outcomes (8)
Progression-free Survival
the time interval from date of first dose of study drug to first documented disease progression or death from any cause, whichever occurs first. The PFS scale ranges from 0 days (for immediate progression or death) to the longest observed duration without progression or death.
Measured: through study completion, an average of 2 years
Disease Control Rate
Disease Control Rate (DCR) is defined as the proportion of subjects who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The scale of DCR ranges from 0% to 100%, where 0% indicates no subjects achieved CR, PR, or SD, and 100% indicates all evaluable subjects achieved disease control (CR, PR, or SD). Subjects who do not have sufficient data to determine response status are excluded from the denominator.
Measured: no longer than 7 months
Overall Survival Rate
Overall survival rate (OSR) is is typically reported as a percentage (%), representing the proportion of subjects who are alive at a specific time point after receiving the first dose of the study drug. The scale of Overall Survival Rate (OSR) ranges from 0% to 100%, where 0% indicates that none of the study participants survived for the specified period after the first dose of the study drug, and 100% indicates that all participants are alive at that time point. A higher OSR percentage suggests a greater proportion of subjects who have survived, reflecting the potential effectiveness of the treatment under investigation.
Measured: up to 6 months
Overall Survival Rate
Overall survival rate (OSR) is is typically reported as a percentage (%), representing the proportion of subjects who are alive at a specific time point after receiving the first dose of the study drug. The scale of Overall Survival Rate (OSR) ranges from 0% to 100%, where 0% indicates that none of the study participants survived for the specified period after the first dose of the study drug, and 100% indicates that all participants are alive at that time point. A higher OSR percentage suggests a greater proportion of subjects who have survived, reflecting the potential effectiveness of the treatment under investigation. Overall Survival at 12 months is not available. Data were only collected up to 6 months.
Measured: up to 12 months
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Measured: Prior to treatment with Abemaciclib (baseline)
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Measured: Cycle 1 (28 days) treatment with Abemaciclib
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Measured: Cycle 2 (56 days) treatment with Abemaciclib
Quality of Life Score
Quality of Life (QoL) will be assessed from the date of baseline and then every 4 weeks using the EORTC QLQ-C30. The QLQ-C30 comprises both multi-item scales and single-item measures, including a global health status/QoL scale, five functional scales, three multi-item symptom scales, and six single-item scales. For the multi-item scales, the raw score (RS) is calculated by taking the mean of the individual item scores. A linear transformation is then applied to standardize the raw score, resulting in a standardized score ranging from 0 to 100, where a score of 0 indicates the worst possible QoL and a score of 100 indicates the best possible QoL.
Measured: Assessment at the end of treatment with Abemaciclib, approximately 60 days after starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start24 Sep 2021
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Why it stopped: The manufacturer and funder Eli Lilly requested to terminate the study
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 Biliary Tract CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study to confirm tolerability of abemaciclib and provide an estimate of the overall response rate. A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Nelson Yee, MD, PhD, Milton S. Hershey Medical Center
- Investigators
- Nelson Yee, MD, Ph.D, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003896
- Sponsor's protocol ID
- PSCI-18-052
- Status last verified
- Sep 2024
- First submitted
- 25 Jun 2019
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma
- ClinicalTrials.gov ID
- NCT04003896
- Acronym / sponsor ID
- PSCI-18-052
- Conditions
- Biliary Tract Carcinoma
- Keywords
- Biliary Tract Carcinoma, Abemaciclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The manufacturer and funder Eli Lilly requested to terminate the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
Detailed description
Biliary Tract Carcinoma (BTC) is a leading cause of cancer-related mortality. The newly developed small molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), abemaciclib, provides a new opportunity of treating patients with BTC. The goal of this clinical study is to determine the efficacy and safety of abemaciclib in patients with advanced or metastatic BTC that has progressed or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician.
The investigator's objectives for this study are as follows:
Primary Objectives:
- To estimate the objective response rate (ORR)
Secondary Objectives:
- To determine progression free survival (PFS)
- To determine the disease control rate (DCR)
- To determine the overall survival (OS) rate at 6 and 12 months
- To determine quality of life (QoL) using EORTC-QLQ-C30
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study to confirm tolerability of abemaciclib and provide an estimate of the overall response rate. A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.
| Arm | Type | Receives |
|---|---|---|
| Abemaciclib | Experimental | Drug: AbemaciclibAbemaciclib will be given as a single oral agent A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female, age ≥ 18 years at the time of informed consent.
- Capable and willing to sign informed consent form prior to performing any protocol-related procedures.
- Histologic or cytologic evidence of advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intra-hepatic or extra-hepatic bile ducts), ampullary carcinoma, or gallbladder carcinoma.
- Evidence of recurrent, locally advanced, unresectable, or metastatic disease.
- Progressed following or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician
Key exclusion criteria (15 listed)
- Ongoing or active infection requiring systemic antibiotics.
- Uncontrolled hypertension despite adequate therapy (systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
- Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
- Active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent, and no known active disease in the 3 years prior to enrollment.
- Primary brain tumor or brain metastases from another primary site.
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 |
|---|---|---|
| AbemaciclibAlso: VerzenioParticipant will take 200 mg capsules or tablets orally twice daily. The participant will be instructed to swallow abemaciclib as a whole tablet and not to chew, crush or split capsules or tablets before swallowing. Participants should not ingest abemaciclib tablets if broken, cracked, or otherwise not intact. Doses should be taken at a approximately the same time every day, twice daily. Capsules or tablets can be taken orally with or without food. If the participant vomits or misses a dose of abemaciclib, the participant will be instructed to take the next dose at its scheduled time. Participants will also be provided with a diary and instructed to keep a twice daily record of the times they have taken their medications and any other events such as vomiting, diarrhea, etc. | Drug | Abemaciclib |
Primary outcome
Overall Response Rate
Time frame: no longer than 7 months
overall response rate (ORR) is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.The scale of ORR ranges from 0% to 100%, where 0% indicates no subjects achieved CR or PR, and 100% indicates all evaluable subjects achieved CR or PR.
8 secondary outcomes
Progression-free Survival
Time frame: through study completion, an average of 2 years
Disease Control Rate
Time frame: no longer than 7 months
Overall Survival Rate
Time frame: up to 6 months
Overall Survival Rate
Time frame: up to 12 months
Quality of Life Score
Time frame: Prior to treatment with Abemaciclib (baseline)
Quality of Life Score
Time frame: Cycle 1 (28 days) treatment with Abemaciclib
Quality of Life Score
Time frame: Cycle 2 (56 days) treatment with Abemaciclib
Quality of Life Score
Time frame: Assessment at the end of treatment with Abemaciclib, approximately 60 days after starting treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Nelson Yee, MD, Ph.D principal investigator
Penn State Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib in people with Biliary Tract Carcinoma, run by Milton S. Hershey Medical Center 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 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Oct 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?
Overall Response Rate (time frame: no longer than 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 8 Oct 2024.