Locally Advanced or Metastatic Solid TumorPhase 1/2NCT03717415
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing Rebastinib and Carboplatin in people with Locally Advanced or Metastatic Solid Tumor, run by Deciphera Pharmaceuticals, LLC at 9 sites in United States.
Trial summary
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumor
- What is being tested?
- Rebastinib and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Jan 2019to 1 Nov 2022
- Phase
- Phase 1/2
- 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 patients ≥18 years of age at the time of informed consent.
- Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment.
- Part 2 (Dose Expansion)
- Previously treated, triple-negative breast cancer.
- Recurrent platinum-sensitive ovarian cancer.
- Histologically confirmed pleural or peritoneal malignant mesothelioma.
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- ECOG performance status of ≤2.
- Able to provide an archival tumor tissue sample.
- Adequate organ function and bone marrow reserve.
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.
- Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Who cannot join
- Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose.
- Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
- Peripheral neuropathy of any etiology >Grade 1.
- Concurrent malignancy.
- Known active CNS metastases.
- Use of systemic corticosteroids.
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- Known retinal neovascularization, macular edema or macular degeneration.
- History or presence of clinically relevant cardiovascular abnormalities.
- QTcF >450 ms in males or >470 ms in females.
- Left ventricular ejection fraction (LVEF) <50% at screening.
- Arterial thrombotic or embolic events.
- Symptomatic venous thrombotic event.
- Active infection ≥Grade 3.
- Known HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
- Use of proton pump inhibitors.
- If female, the patient is pregnant or lactating.
- Major surgery 4 weeks prior to the first dose of study drug.
- Malabsorption syndrome or other illness which could affect oral absorption.
- Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
- Any other clinically significant comorbidities.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
The Ohio State University
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
NEXT Oncology
San Antonio, Texas, 78240
University of California San Francisco (UCSF)
San Francisco, California, 94115
UCLA Medical Center
Santa Monica, California, 90404
About this study
Official title: An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.
- Being tested
- Rebastinib, Carboplatin
- Keywords
- rebastinib, breast cancer, ovarian cancer, mesothelioma
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Ovarian Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebastinibDrug
Also called DCC-2036
Administered orally
CarboplatinDrug
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | Experimental | Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. Receives: Drug: Rebastinib; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
Measured: Baseline up to 2.32 years
Objective Response Rate (ORR) (Dose Expansion Phase)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Secondary outcomes (7)
Objective Response Rate (ORR) (Dose Escalation Phase)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Duration of Response (DOR)
Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment per Response Evaluation Criteria in Solid Tumor (RECIST v1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)
Time to Progression (TTP)
Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions.
Measured: First Dose of Study Drug to PD (Up to 1.63 years)
Progression-free-survival (PFS)
Time from first dose of study drug to disease progression (PD) or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. Disease progression per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: First Dose of Study Drug to PD or Death due to Any Cause (up to 1.63 years)
Overall Survival (OS)
Time from baseline C1 D1 to date of death due to any cause. Participants who are still alive or who are lost to follow-up will be censored at the date of last contact.
Measured: Baseline to death due to any cause (Up to 2.12 years)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Cmax of rebastinib
Measured: Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
Measure the AUC 0-3 hours
Measured: Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start2 Jan 2019
- Primary completion1 May 2022
- Study completion1 Nov 2022
Why it stopped: Development program terminated.
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 Locally Advanced or Metastatic Solid TumorStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717415
- Sponsor's protocol ID
- DCC-2036-01-004
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2018
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03717415
- Acronym / sponsor ID
- DCC-2036-01-004
- Keywords
- rebastinib, breast cancer, ovarian cancer, mesothelioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development program terminated.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle. |
| Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
| Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle. |
| Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
| Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
| Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
| Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
| Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
| Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5 | Experimental | Drug: Rebastinib, Drug: CarboplatinDose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients ≥18 years of age at the time of informed consent.
- Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment.
- Part 2 (Dose Expansion)
- ECOG performance status of ≤2.
- Able to provide an archival tumor tissue sample.
Key exclusion criteria (20 listed)
- Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose.
- Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
- Peripheral neuropathy of any etiology >Grade 1.
- Concurrent malignancy.
- Known active CNS metastases.
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 |
|---|---|---|
| RebastinibAlso: DCC-2036Administered orally | Drug | Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5, Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5, Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6, Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5, Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5, Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5, Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5, Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5, Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 |
| CarboplatinAdministered by IV infusion | Drug | Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5, Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5, Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6, Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5, Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5, Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5, Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5, Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5, Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5 |
Primary outcome
Number of Participants With Adverse Events
Time frame: Baseline up to 2.32 years
Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
Objective Response Rate (ORR) (Dose Expansion Phase)
Time frame: Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
7 secondary outcomes
Objective Response Rate (ORR) (Dose Escalation Phase)
Time frame: Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Duration of Response (DOR)
Time frame: Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)
Time to Progression (TTP)
Time frame: First Dose of Study Drug to PD (Up to 1.63 years)
Progression-free-survival (PFS)
Time frame: First Dose of Study Drug to PD or Death due to Any Cause (up to 1.63 years)
Overall Survival (OS)
Time frame: Baseline to death due to any cause (Up to 2.12 years)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Time frame: Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
Time frame: Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rebastinib and Carboplatin in people with Locally Advanced or Metastatic Solid Tumor, run by Deciphera Pharmaceuticals, LLC at 9 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 20 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 combined 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.
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 27 Dec 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 Adverse Events (time frame: Baseline up to 2.32 years). 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 27 Dec 2024.