Metastatic Castration-resistant Prostate CancerPhase 1CaboLuNCT05613894
Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing Cabozantinib in people with Metastatic Castration-resistant Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Cabozantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2023to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
- Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
- Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation anti-androgen therapies that include, but are not limited to, abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
- Must be eligible for therapy with 177Lu-PSMA-617 and have ≥ 1 PSMA-positive lesion per treating investigator.
- Must have progressive mCRPC per the treating investigator.
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- ECOG Performance Status ≤ 1.
- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony-stimulating factor support
- White blood cell count ≥ 3000/µL.
- Platelet count ≥ 100,000/µL
- Hemoglobin ≥ 9g/dL
- Serum albumin ≥ 2.5 g/dl
- PT/INR or partial thromboplastin time (PTT) test < 1.3x the laboratory ULN
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- For subjects with Gilbert's disease: ≤ 3x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).
- Renal:
- Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g
- Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
- Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study treatment in accordance with section 5.4.2.
- Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Patients must have a life expectancy >3 months.
Who cannot join
- Receiving other investigational anti-cancer agents.
- Prior treatment with cabozantinib
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization.
- Previous PSMA-targeted radioligand therapy
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
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- Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment.
- Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.
- Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis).
- Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment.
- Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
- Major surgery within 4 weeks prior to starting study drug, minor surgery within 10 days, or subjects who have not fully recovered from major surgery.
- Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast.
- Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
- Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH)
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before the first dose of study treatment.
- Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion 14) for at least 1 week before first dose of study treatment.
- Uncontrolled hypertension defined as sustained blood pressure (BP) ≥ 150 mm Hg systolic or >90 mmHg diastolic despite optimal antihypertensive treatment.
- Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
- The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.
- Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.)
- Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
- Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
- Lesions invading or encasing any major blood vessels
- Other clinically significant disorders that would preclude safe study participation.
- Serious non-healing wound/ulcer/bone fracture.
- Uncompensated/symptomatic hypothyroidism.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- Known history of COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to first dose of study treatment.
- Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment or minor surgeries within 10 days before first dose of study treatment.
- Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment.
- --Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.
- --Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
- Inability to swallow tablets
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
- --Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
- Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
- Subjects taking prohibited medications as described in Section 6.8.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Susan Sharry, 801-585-3453, susan.sharry@hci.utah.edu
About this study
Official title: A Phase Ib Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. The dose-escalation phase (Part 1) will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule for the subsequent expansion phase (Part 2).
- Being tested
- Cabozantinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Also called 177Lu-PSMA-617
(177Lu)-PSMA-617 will be administered every 6 weeks for up to 6 cycles per SOC. Oral Cabozantinib taken daily at home.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Part 1) | Experimental | Part 1 will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule Receives: Drug: Cabozantinib |
| Dose Expansion Cohort (Part 2) | Experimental | Expansion Phase to assess identified MTD and schedule from Part 1. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
To determine the maximum tolerated dose (MTD) and recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with metastatic castration-resistant prostate cancer (mCRPC) when taken in combination with 177Lu-PSMA-617
Measured: 28 days
The proportion of patients without progression as defined by PCWG3-modified RECIST 1.1 at 24 weeks.
To evaluate preliminary efficacy by estimating the progression-free survival (PFS) at 24 weeks (PFS24w) as assessed by per PCWG3-modified RECIST v1.1
Measured: 24 weeks
Secondary outcomes (8)
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NCI CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
To assess the safety and tolerability of 177Lu-PSMA and cabozantinib in the study population
Measured: up to 2 years
ORR, defined as the proportion of subjects with measurable disease achieving a confirmed PR and CR as defined by PCWG3-modified RECIST 1.1.
To assess the objective response rate (ORR) in the study population.
Measured: 3 years
DoR, defined as the interval of time from the date of initial documented response (PR or better per PCWG3-modified RECIST 1.1) to the time of progression from the best response, the start of a new therapy, or death from any cause.
To assess the duration of response (DoR) of the study population.
Measured: up to 3 years
rPFS as assessed by PCWG3-modified RECIST 1.1 from start of therapy to the time of radiographic progression or death from any cause.
To assess the radiographic PFS (rPFS) of the study population.
Measured: up to 3 years
The proportion of patients without progression as defined by PCWG3-modified RECIST 1.1 at 38 weeks.
To evaluate PFS at 38 weeks (PFS38w) as assessed by per PCWG3-modified RECIST v1.1.
Measured: 38 weeks
The levels of PSA will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of PSA progression, as defined by PCWG3 criteria.
To assess the PSA PFS of the study population.
Measured: 4 weeks
The levels of PSA will be monitored per treatment schedule to assess the proportion of patients with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment.
To assess the PSA 50% response rate in the study population.
Measured: up to 2 years
OS as defined as the time from registration until death from any cause.
To assess overall survival (OS) in this study population
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start14 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A standard 3+3 dose escalation design will be used to identify the MTD and/or recommended dose and schedule for the subsequent expansion phase. The study was originally designed to test 2 dose levels of cabozantinib with the option to dose reduce to dose level -1. As of amendment version 20MAY2026, dose level 2 has been removed.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Exelixis
- Responsible party
- Sponsor
- Investigators
- Umang Swami, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613894
- Sponsor's protocol ID
- 157278
- Acronym
- CaboLu
- Status last verified
- Jun 2026
- First submitted
- 4 Nov 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT05613894
- Acronym / sponsor ID
- CaboLu / 157278
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Exelixis
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. The dose-escalation phase (Part 1) will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule for the subsequent expansion phase (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A standard 3+3 dose escalation design will be used to identify the MTD and/or recommended dose and schedule for the subsequent expansion phase. The study was originally designed to test 2 dose levels of cabozantinib with the option to dose reduce to dose level -1. As of amendment version 20MAY2026, dose level 2 has been removed.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Part 1) | Experimental | Drug: CabozantinibPart 1 will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule |
| Dose Expansion Cohort (Part 2) | Experimental | Drug: CabozantinibExpansion Phase to assess identified MTD and schedule from Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male subject aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
- Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
- Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation anti-androgen therapies that include, but are not limited to, abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
- Must be eligible for therapy with 177Lu-PSMA-617 and have ≥ 1 PSMA-positive lesion per treating investigator.
Key exclusion criteria (50 listed)
- Receiving other investigational anti-cancer agents.
- Prior treatment with cabozantinib
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization.
- Previous PSMA-targeted radioligand therapy
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
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 |
|---|---|---|
| CabozantinibAlso: 177Lu-PSMA-617(177Lu)-PSMA-617 will be administered every 6 weeks for up to 6 cycles per SOC. Oral Cabozantinib taken daily at home. | Drug | Dose Escalation (Part 1), Dose Expansion Cohort (Part 2) |
Primary outcome
The rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Time frame: 28 days
To determine the maximum tolerated dose (MTD) and recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with metastatic castration-resistant prostate cancer (mCRPC) when taken in combination with 177Lu-PSMA-617
The proportion of patients without progression as defined by PCWG3-modified RECIST 1.1 at 24 weeks.
Time frame: 24 weeks
To evaluate preliminary efficacy by estimating the progression-free survival (PFS) at 24 weeks (PFS24w) as assessed by per PCWG3-modified RECIST v1.1
8 secondary outcomes
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NCI CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
Time frame: up to 2 years
ORR, defined as the proportion of subjects with measurable disease achieving a confirmed PR and CR as defined by PCWG3-modified RECIST 1.1.
Time frame: 3 years
DoR, defined as the interval of time from the date of initial documented response (PR or better per PCWG3-modified RECIST 1.1) to the time of progression from the best response, the start of a new therapy, or death from any cause.
Time frame: up to 3 years
rPFS as assessed by PCWG3-modified RECIST 1.1 from start of therapy to the time of radiographic progression or death from any cause.
Time frame: up to 3 years
The proportion of patients without progression as defined by PCWG3-modified RECIST 1.1 at 38 weeks.
Time frame: 38 weeks
The levels of PSA will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of PSA progression, as defined by PCWG3 criteria.
Time frame: 4 weeks
The levels of PSA will be monitored per treatment schedule to assess the proportion of patients with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment.
Time frame: up to 2 years
OS as defined as the time from registration until death from any cause.
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Umang Swami, MD principal investigator
Huntsman 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 1 study testing Cabozantinib in people with Metastatic Castration-resistant Prostate Cancer, run by University of Utah 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 26 inclusion and 50 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Sharry (801-585-3453, susan.sharry@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of dose-limiting toxicities (DLTs) during the DLT evaluation period (time frame: 28 days). 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 12 Aug 2026.