Metastatic Lung Non-Small Cell CarcinomaPhase 1NCT06067776
Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer
A Phase 1 study testing Cetuximab, Osimertinib and Tucatinib in people with Metastatic Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by Jonathan Riess at 1 site in United States.
Trial summary
This phase I trial tests the safety, side effects, and best dose of osimertinib, cetuximab, and tucatinib in treating patients with EFGR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Cetuximab, Osimertinib and Tucatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Nov 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with Stage IV or recurrent/metastatic histologically confirmed non-small cell lung cancer (NSCLC).
- NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, Exon 20 S768I.
- For patients in the dose escalation cohort, patients must have progressed on any prior EGFR-Tyrosine Kinase Inhibitor (TKI) and if T790M positive must have also progressed on osimertinib. Participants in the dose expansion cohort must have had progressive disease as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version (v)1.1 criteria on osimertinib as first-line therapy.
- 4. Participants in the dose expansion cohort must be negative for clinically significant non-ERBB bypass tract resistance such as MET amplification, BRAF mutation, RAS-RAF-MAPK alteration, ALK fusion, RET fusion by a Clinical Laboratory Improvement Amendments (CLIA) (performed after progression on prior EGFR-TKI; if any questions please consult with the Principal Investigator). A defined subset of patients in the expansion cohort will have human epidermal growth factor receptor (HER2) aberrant signaling as putative resistance to osimertinib with overexpression/amplification (or more rarely HER2 Exon 20 insertion mutation) as determined by IHC (3+ IHC) or FISH (HER2/CEP17 > 2.2 or HER2 copy number > 6) or NGS for HER2 mutation.
- Adequate archival tissue from a biopsy performed after progression of disease on previous osimertinib (or last EGFR-TKI for dose escalation cohort) or willingness to consent for a fresh tumor biopsy.
- Participants must have measurable disease by RECIST 1.1, by positron emission tomography/computed tomography (PET/CT) or CT imaging within 28 days prior to registration. The CT from a combined PET/CT may be used only if it is of diagnostic quality.
Show all 26Show fewer
- Men and women >=18 years of age at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy greater than 3 months.
- Absolute neutrophil count >= 1.5 x 10^9/L.
- Platelets >= 100 x 10^9/L.
- Hemoglobin >= 9 g/dL.
- Serum albumin >= 2.5 g/dL.
- Bilirubin =< 1.5 x the upper limit of normal (ULN).
- Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate transaminase (AST) =< 2.5 x ULN.
- Potassium within institutional normal limits.
- Magnesium within institutional normal limits.
- Coagulation parameters of international normalized ratio (INR) < 1.5 and partial thromboplastin time (PTT) < 30 seconds.
- Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min (per the Cockcroft-Gault formula).
- If brain metastases are present, they must be stable and asymptomatic. Participants on corticosteroids for brain metastases are excluded.
- Left ventricular ejection fraction 50% or more on echocardiogram or multigated acquisition scan.
- Individuals of child-bearing potential must test negative for pregnancy =< 14 days prior to receiving first dose of study medication based on a serum pregnancy test and agree to use 2 methods of birth control or abstain from heterosexual activity during the study and for 6 months following the last dose of the study drug(s), whichever is longer; or be of non- childbearing potential. Non-childbearing potential is defined as (by other than medical reasons) * >= 45 years of age and has not had menses for greater than 2 years. * Amenorrheic for < 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation. *Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed (of the actual procedure or confirmed by an ultrasound). Tubal ligation must be confirmed (of the actual procedure) otherwise the participant must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study therapy.
- Ability to swallow pills.
- Ability to understand and willingness to sign an informed consent form.
- Ability to adhere to the study visit schedule and protocol requirements.
- Participants previously on osimertinib allowed to continue prior to initiating study.
Who cannot join
- History of pneumonitis requiring steroids, including history of radiation-induced pneumonitis.
- Known or suspected leptomeningeal disease as documented by the investigator. Stable asymptomatic brain metastases not requiring steroids is allowed; radiation for brain metastases is allowed as long as there is a two-week washout period prior to starting study treatment.
- Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding central nervous system (CNS)-directed therapy.
- The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components (including any ingredient or similar ingredient used in the product formulations) or red meat.
- History of tick bite or any other contraindication to one of the administered treatments.
- History of arterial or venous thromboembolism within 3 months prior to study enrollment. Participants with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin or direct oral anti-coagulants.
Show all 21Show fewer
- History or evidence of current clinically relevant coronary artery disease >= Grade III by the Canadian Cardiovascular Society Angina Grading Scale or uncontrolled congestive heart failure of current > Class III as defined by the New York Heart Association.
- The participant has experienced myocardial infarction within 6 months prior to study enrollment.
- The participant has a history of clinically significant ventricular arrhythmia, cardiac arrest, or torsades de pointes.
- The participant has high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
- The participant has uncontrolled or poorly controlled hypertension (>180 mmHg systolic or > 130 mmHg diastolic.
- Use of a strong cytochrome P450 CYP2C8 inhibitor within 5 half-lives of the inhibitor or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to the first dose of study treatment.
- The participant is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
- The participant has any ongoing or active clinically significant infection, including known active tuberculosis or known ongoing or active infection with the human immunodeficiency virus.
- Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
- Any condition that would prohibit the understanding or rendering of informed consent.
- Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial.
- Radiation within 14 days before beginning study drugs.
- Prior EGFR monoclonal antibody treatment (i.e., necitumumab or cetuximab) or HER2 directed treatment (i.e., trastuzumab deruxtecan) for dose expansion only.
- Any systemic therapy within 3 weeks of enrollment with the exception of EGFR-TKI. * Platinum-based chemotherapy or other lines of intervening systemic therapy after progression on osimertinib or EGFR TKIs is allowed but must be completed no later than 3 weeks before study enrollment.
- Prior EGFR-TKI (if not osimertinib) must be discontinued at least 7 days prior to start of study treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Jonathan W. Riess, 916-734-3772, jwriess@ucdavis.edu
Jonathan W. Riess
About this study
Official title: A Phase I Study of Osimertinib, Cetuximab, and Tucatinib in Advanced EGFR-Mutant NSCLC With Acquired Resistance to Osimertinib
This phase I trial tests the safety, side effects, and best dose of osimertinib, cetuximab, and tucatinib in treating patients with EFGR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent). Osimertinib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Cetuximab is a chimeric human/mouse IgG1 monoclonal antibody that targets epidermal growth factor receptor (EGFR), a receptor overexpressed in many types of cancer, and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib, cetuximab, and tucatinib may work better in treating patients with non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVE :
- To estimate the maximum tolerated dose (MTD) of osimertinib, cetuximab, and tucatinib in participants with EGFR-mutant non-small cell lung cancer (NSCLC) who have acquired resistance to EGFR-tyrosine kinase inhibitor (TKI).
SECONDARY OBJECTIVES:
- To evaluate the toxicities of osimertinib, cetuximab, and tucatinib in participants with EGFR-mutant NSCLC who have acquired resistance to EGFR-TKI.
II. To obtain preliminary assessment of anti-tumor activity of osimertinib, cetuximab, and tucatinib in participants with EGFR-mutant NSCLC who have acquired resistance to EGFR-TKI (osimertinib).
III. To obtain preliminary assessment of anti-tumor activity of osimertinib, cetuximab, and tucatinib in the dose expansion cohort of participants with EGFR-mutant NSCLC who progressed on first-line osimertinib and do not have non-ERBB bypass tract mechanisms of resistance, including a subset of participants positive for HER2 aberrant signaling as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and/or next generation sequencing (NGS).
OUTLINE:
This is a dose-escalation study of tucatinib and cetuximab. Patients receive tucatinib 200mg orally BID, osimertinib 80mg orally daily, and cetuximab 250mg/m^2 IV every 2 weeks of a 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 12 weeks for up to 2 years.
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- Being tested
- Cetuximab, Osimertinib, Tucatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabBiological
Also called ERBITUX
Given IV
OsimertinibDrug
Also called TAGRISSO
Given PO
TucatinibDrug
Also called TUKYSA
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (tucatinib, osimertinib, cetuximab) | Experimental | Patients receive tucatinib 200mg orally BID, osimertinib 80mg orally daily, and cetuximab 250mg/m^2 IV every 2 weeks of a 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Cetuximab; Drug: Osimertinib; Drug: Tucatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
The occurrence of a dose-limiting toxicity in participants receiving the combination of osimertinib, cetuximab, and tucatinib.
Measured: First dose through cycle 1 (each cycle is 28 days)
Secondary outcomes (3)
Incidence of adverse events
Number of participants experiencing adverse events (AEs), both non treatment related and treatment related, classified by severity and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Measured: First dose through 30 days post last dose
Objective response rate (ORR)
Objective response rate (ORR), assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Measured: First dose through progression or end of study treatment, whichever occurs first, assessed up to 10 months
Progression-free survival (PFS)
Measured: Up to 2 years post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lung Non-Small Cell 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonathan Riess
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Jonathan Riess, University of California, Davis
- Investigators
- Jonathan W Riess, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067776
- Sponsor's protocol ID
- UCDCC#298
- Other IDs
- NCI-2022-04431, UCDCC#298, P30CA093373
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- 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 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Osimertinib, Cetuximab, and Tucatinib in Advanced EGFR-Mutant NSCLC With Acquired Resistance to Osimertinib
- ClinicalTrials.gov ID
- NCT06067776
- Acronym / sponsor ID
- UCDCC#298
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jonathan RiessUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 5 Oct 2023 (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 phase I trial tests the safety, side effects, and best dose of osimertinib, cetuximab, and tucatinib in treating patients with EFGR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent). Osimertinib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Cetuximab is a chimeric human/mouse IgG1 monoclonal antibody that targets epidermal growth factor receptor (EGFR), a receptor overexpressed in many types of cancer, and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib, cetuximab, and tucatinib may work better in treating patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVE :
- To estimate the maximum tolerated dose (MTD) of osimertinib, cetuximab, and tucatinib in participants with EGFR-mutant non-small cell lung cancer (NSCLC) who have acquired resistance to EGFR-tyrosine kinase inhibitor (TKI).
SECONDARY OBJECTIVES:
- To evaluate the toxicities of osimertinib, cetuximab, and tucatinib in participants with EGFR-mutant NSCLC who have acquired resistance to EGFR-TKI.
II. To obtain preliminary assessment of anti-tumor activity of osimertinib, cetuximab, and tucatinib in participants with EGFR-mutant NSCLC who have acquired resistance to EGFR-TKI (osimertinib).
III. To obtain preliminary assessment of anti-tumor activity of osimertinib, cetuximab, and tucatinib in the dose expansion cohort of participants with EGFR-mutant NSCLC who progressed on first-line osimertinib and do not have non-ERBB bypass tract mechanisms of resistance, including a subset of participants positive for HER2 aberrant signaling as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and/or next generation sequencing (NGS).
OUTLINE:
This is a dose-escalation study of tucatinib and cetuximab. Patients receive tucatinib 200mg orally BID, osimertinib 80mg orally daily, and cetuximab 250mg/m^2 IV every 2 weeks of a 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 12 weeks for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (tucatinib, osimertinib, cetuximab) | Experimental | Biological: Cetuximab, Drug: Osimertinib, Drug: TucatinibPatients receive tucatinib 200mg orally BID, osimertinib 80mg orally daily, and cetuximab 250mg/m^2 IV every 2 weeks of a 28-day cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Participants with Stage IV or recurrent/metastatic histologically confirmed non-small cell lung cancer (NSCLC).
- NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, Exon 20 S768I.
- For patients in the dose escalation cohort, patients must have progressed on any prior EGFR-Tyrosine Kinase Inhibitor (TKI) and if T790M positive must have also progressed on osimertinib. Participants in the dose expansion cohort must have had progressive disease as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version (v)1.1 criteria on osimertinib as first-line therapy.
- 4. Participants in the dose expansion cohort must be negative for clinically significant non-ERBB bypass tract resistance such as MET amplification, BRAF mutation, RAS-RAF-MAPK alteration, ALK fusion, RET fusion by a Clinical Laboratory Improvement Amendments (CLIA) (performed after progression on prior EGFR-TKI; if any questions please consult with the Principal Investigator). A defined subset of patients in the expansion cohort will have human epidermal growth factor receptor (HER2) aberrant signaling as putative resistance to osimertinib with overexpression/amplification (or more rarely HER2 Exon 20 insertion mutation) as determined by IHC (3+ IHC) or FISH (HER2/CEP17 > 2.2 or HER2 copy number > 6) or NGS for HER2 mutation.
- Adequate archival tissue from a biopsy performed after progression of disease on previous osimertinib (or last EGFR-TKI for dose escalation cohort) or willingness to consent for a fresh tumor biopsy.
Key exclusion criteria (21 listed)
- History of pneumonitis requiring steroids, including history of radiation-induced pneumonitis.
- Known or suspected leptomeningeal disease as documented by the investigator. Stable asymptomatic brain metastases not requiring steroids is allowed; radiation for brain metastases is allowed as long as there is a two-week washout period prior to starting study treatment.
- Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding central nervous system (CNS)-directed therapy.
- The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components (including any ingredient or similar ingredient used in the product formulations) or red meat.
- History of tick bite or any other contraindication to one of the administered treatments.
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 |
|---|---|---|
| CetuximabAlso: ERBITUXGiven IV | Biological | Treatment (tucatinib, osimertinib, cetuximab) |
| OsimertinibAlso: TAGRISSOGiven PO | Drug | Treatment (tucatinib, osimertinib, cetuximab) |
| TucatinibAlso: TUKYSAGiven PO | Drug | Treatment (tucatinib, osimertinib, cetuximab) |
Primary outcome
Dose-limiting toxicity
Time frame: First dose through cycle 1 (each cycle is 28 days)
The occurrence of a dose-limiting toxicity in participants receiving the combination of osimertinib, cetuximab, and tucatinib.
3 secondary outcomes
Incidence of adverse events
Time frame: First dose through 30 days post last dose
Objective response rate (ORR)
Time frame: First dose through progression or end of study treatment, whichever occurs first, assessed up to 10 months
Progression-free survival (PFS)
Time frame: Up to 2 years post last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Related trials for Metastatic Lung Non-Small Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Jonathan W Riess principal investigator
University of California, Davis
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 Cetuximab, Osimertinib and Tucatinib in people with Metastatic Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by Jonathan Riess 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 21 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selina Laqui (916-734-0565, sblaqui@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: First dose through cycle 1 (each cycle is 28 days)). 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 5 Oct 2023.