Breast CancerPhase 2NCT04172597
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
A Phase 2 study testing Poziotinib Hydrochloride and Loperamide in people with Breast Cancer and Colorectal Cancer, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Solid Tumor
- What is being tested?
- Poziotinib Hydrochloride and Loperamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2019to 29 Mar 2022
- 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
- Patients must be at least 18 years old.
- Patients must have histologic or cytologic evidence of a malignant solid cancer that is either advanced or metastatic there must be no available therapy known to confer a reasonable likelihood of clinical benefit.
- Patients with BC must have a HER2 activating mutation determined by next-generation sequencing (NGS) performed on either tumor or plasma samples and:
- Immunohistochemistry (IHC) HER2-positive BC that has progressed on trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) in the metastatic setting, unless there is recurrent disease within 12 months of adjuvant or neoadjuvant treatment.
- IHC HER2-negative, estrogen receptor/progesterone receptor (ER/PR)-positive BC that has progressed on or after appropriate first-line endocrine therapy in the metastatic setting.
- IHC HER2-negative, ER/PR-negative BC that has progressed after first-line treatment (any standard chemotherapy-based regimen) in the metastatic setting.
Show all 14Show fewer
- Patients with microsatellite instability-high (MSI-H) CRC must have had appropriate checkpoint inhibitor-based therapy.
- Patient's tumor must be positive for an EGFR or HER2 mutation based on DNA testing of either tumor tissue or plasma samples. Patients with documented EGFR or HER2 mutations may be identified by local testing from participating sites using next generation sequencing tests. Patient has a solid tumor with at least one of the listed activating mutations:
- Cohorts 1-3: HER2 Activating Mutations (at least one of the following) Furin-Like/Extracellular. S310F/Y Transmembrane. I655V, V659E, R678Q, V697L Kinase Domain. Exon 20 insertion, T733I, L755X, I767M, D769X, V773M, V777X, L786V, V842I, T862I, L869R.
- Cohorts 4-5: EGFR Activating Mutations (at least one of the following) Extracellular \& Transmembrane: EGFRvIII, R108K, R222C, A289T, P596L, G598V Kinase Domain: Exon 20 insertion, E709X, E709_T710del insD, L718X, G719X, I740_K745dupIPVAIK, I740_K745dup, V742I, L747X, E746_A750del, A750P, S768I, S768I/V769L, S768I/V774M, L833V, V769M, V774M, R831C, R831H, L858R, L861Q, A864V.
- Patients must have measurable disease.
- Patients with central nervous system (CNS) metastases must have stable CNS disease and no evidence of growth on imaging for at least 4 weeks following radiation or other locoregional ablative therapy. CNS symptoms must be stable with no requirement for anti-seizure medications and/or > 2 mg/day dexamethasone equivalent, except for patients with GBM (Cohort 4), in whom anti-seizure medications and/or up to 4 mg/day dexamethasone equivalent is allowed.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ -1.
- Patients must have adequate hematopoietic, renal, and liver functions.
Who cannot join
- Patient has an EGFR T790 mutation.
- Patient has breast or gastric cancer without eligible HER2 mutations (see Inclusion Criteria).
- Patients with GBM enrolled in Cohort 4 has been treated with an inhibitor of vascular endothelial growth factor (VEGF) inhibitor therapy (e.g., bevacizumab).
- Patient requires treatment with a medication that is a strong inhibitor or inducer of CYP3A4 or CYP2D6 or has been treated with such medications within 15 days of poziotinib treatment.
- Patient has ≥ Grade 2 skin disorders (rash), mucositis, or stomatitis within 15 days of poziotinib treatment.
- Patient has a gastrointenstinal disorder or malabsorption that precludes oral drug treatment.
Show all 13Show fewer
- Patient has active liver or biliary tract disease (except for Gilbert's syndrome, asymptomatic biliary stones, liver metastasis, or stable chronic liver diseases).
- Patient has a history of drug-induced pancreatitis.
- Patient has a history of interstitial lung disease or pneumonitis.
- Patient has a history of congestive heart failure Class III/IV according to the New York Heart Association Functional Classification or a serious cardiac arrhythmia requiring treatment.
- Patient has a high risk of cardiac disease as determined by the Investigator. If patient is deemed to have a high cardiac risk, enrollment may be considered if an echocardiogram (ECHO) or multi-gated acquisition (MUGA) during Screening demonstrates a cardiac ejection fraction >= 50%.
- Patient has a QTc interval > 470 ms.
- Patient has a history of another malignancy within the 1 year prior to poziotinib treatment. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in situ), organ-confined prostate cancer with no evidence of progressive disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Shores Medical Group
Long Beach, California, 90813
About this study
Official title: A Phase 2 Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
Read the detailed description
The Screening period (Day -30 to Day 1) begins 30 days prior to poziotinib treatment on Day 1 of Cycle 1. Patients must meet all Inclusion/Exclusion Criteria and provide informed written consent prior to study procedures.
The duration of each treatment cycle is 28 days. There will be five patient cohorts. Eligible patients will be enrolled into cohorts concurrently based on EGFR or HER2 exon 20 mutation status.
- Cohort 1: HER2-positive or HER2-negative breast cancer (BC) with a HER2 activating mutation.
- Cohort 2: Colorectal cancer (CRC) with a HER2 activating mutation.
- Cohort 3: Any solid cancer, except non-small cell lung cancer (NSCLC), BC, or CRC with a HER2 activating mutation.
- Cohort 4: Glioblastome multiforma (GBM) with an EGFR activating mutation.
- Cohort 5: Any solid cancer, except NSCLC or GBM with an EGFR activating mutation.
All patients will be treated daily for up to 24 months unless there is disease progression, death, intolerable adverse events (AEs), or another protocol-specified reason for patient withdrawal. After treatment discontinuation, patients will be contacted every 3 months for up to 2 years after the first dose of poziotinib to assess survival.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Being tested
- Poziotinib Hydrochloride, Loperamide
- Keywords
- EGFR activating mutations, HER2 activating mutations, HER2-positive breast cancer, HER2-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poziotinib HydrochlorideDrug
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
LoperamideDrug
Loperamide as prescribed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients with HER2-positive or HER2-negative BC with a HER2 activating mutation will receive poziotinib 8 milligrams (mg), orally, twice daily (BID) starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. Receives: Drug: Poziotinib Hydrochloride; Drug: Loperamide |
| Cohort 2 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. Receives: Drug: Poziotinib Hydrochloride; Drug: Loperamide |
| Cohort 3 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. Receives: Drug: Poziotinib Hydrochloride; Drug: Loperamide |
| Cohort 4 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. Receives: Drug: Poziotinib Hydrochloride; Drug: Loperamide |
| Cohort 5 | Experimental | Patients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. Receives: Drug: Poziotinib Hydrochloride; Drug: Loperamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Measured: Up to 168 days
Secondary outcomes (3)
Duration of Response (DoR)
Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression (PD) is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Measured: Up to 168 days
Disease Control Rate (DCR)
DCR is defined as percentage of participants with best response of CR, PR, and stable disease (SD) from the first dose of poziotinib to the end of study. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter (LD) since the treatment started.
Measured: Up to 168 days
Percentage of Participants With AE
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: Up to 30 days after last dose of study drug (Up to 199 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start23 Dec 2019
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Why it stopped: Strategic business decision (unrelated to safety)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each treatment cycle is 28 calendar days in duration. This is a basket study with five distinct cohorts. Eligible patients will be enrolled into the five cohorts concurrently based on tumor type and mutational status.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaba Kokhreidze, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172597
- Sponsor's protocol ID
- SPI-POZ-203
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2019
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04172597
- Acronym / sponsor ID
- SPI-POZ-203
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Keywords
- EGFR activating mutations, HER2 activating mutations, HER2-positive breast cancer, HER2-negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic business decision (unrelated to safety)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
Detailed description
The Screening period (Day -30 to Day 1) begins 30 days prior to poziotinib treatment on Day 1 of Cycle 1. Patients must meet all Inclusion/Exclusion Criteria and provide informed written consent prior to study procedures.
The duration of each treatment cycle is 28 days. There will be five patient cohorts. Eligible patients will be enrolled into cohorts concurrently based on EGFR or HER2 exon 20 mutation status.
- Cohort 1: HER2-positive or HER2-negative breast cancer (BC) with a HER2 activating mutation.
- Cohort 2: Colorectal cancer (CRC) with a HER2 activating mutation.
- Cohort 3: Any solid cancer, except non-small cell lung cancer (NSCLC), BC, or CRC with a HER2 activating mutation.
- Cohort 4: Glioblastome multiforma (GBM) with an EGFR activating mutation.
- Cohort 5: Any solid cancer, except NSCLC or GBM with an EGFR activating mutation.
All patients will be treated daily for up to 24 months unless there is disease progression, death, intolerable adverse events (AEs), or another protocol-specified reason for patient withdrawal. After treatment discontinuation, patients will be contacted every 3 months for up to 2 years after the first dose of poziotinib to assess survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Each treatment cycle is 28 calendar days in duration. This is a basket study with five distinct cohorts. Eligible patients will be enrolled into the five cohorts concurrently based on tumor type and mutational status.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Poziotinib Hydrochloride, Drug: LoperamidePatients with HER2-positive or HER2-negative BC with a HER2 activating mutation will receive poziotinib 8 milligrams (mg), orally, twice daily (BID) starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
| Cohort 2 | Experimental | Drug: Poziotinib Hydrochloride, Drug: LoperamidePatients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
| Cohort 3 | Experimental | Drug: Poziotinib Hydrochloride, Drug: LoperamidePatients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
| Cohort 4 | Experimental | Drug: Poziotinib Hydrochloride, Drug: LoperamidePatients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
| Cohort 5 | Experimental | Drug: Poziotinib Hydrochloride, Drug: LoperamidePatients with CRC with a HER2 activating mutation will receive poziotinib 8 mg, orally, BID starting on Day 1 of each 28 day cycle for up to 24 months unless there is disease progression, death, intolerable AEs, or another protocol-specified reason for participant withdrawal. Loperamide may be prescribed for the treatment of diarrhea as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must be at least 18 years old.
- Patients must have histologic or cytologic evidence of a malignant solid cancer that is either advanced or metastatic there must be no available therapy known to confer a reasonable likelihood of clinical benefit.
- Patients with BC must have a HER2 activating mutation determined by next-generation sequencing (NGS) performed on either tumor or plasma samples and:
- Patients with microsatellite instability-high (MSI-H) CRC must have had appropriate checkpoint inhibitor-based therapy.
- Patient's tumor must be positive for an EGFR or HER2 mutation based on DNA testing of either tumor tissue or plasma samples. Patients with documented EGFR or HER2 mutations may be identified by local testing from participating sites using next generation sequencing tests. Patient has a solid tumor with at least one of the listed activating mutations:
Key exclusion criteria (13 listed)
- Patient has an EGFR T790 mutation.
- Patient has breast or gastric cancer without eligible HER2 mutations (see Inclusion Criteria).
- Patients with GBM enrolled in Cohort 4 has been treated with an inhibitor of vascular endothelial growth factor (VEGF) inhibitor therapy (e.g., bevacizumab).
- Patient requires treatment with a medication that is a strong inhibitor or inducer of CYP3A4 or CYP2D6 or has been treated with such medications within 15 days of poziotinib treatment.
- Patient has ≥ Grade 2 skin disorders (rash), mucositis, or stomatitis within 15 days of poziotinib 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 |
|---|---|---|
| Poziotinib HydrochlorideThe poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| LoperamideLoperamide as prescribed by the physician. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 168 days
ORR was defined as the percentage of participants with confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
3 secondary outcomes
Duration of Response (DoR)
Time frame: Up to 168 days
Disease Control Rate (DCR)
Time frame: Up to 168 days
Percentage of Participants With AE
Time frame: Up to 30 days after last dose of study drug (Up to 199 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Jaba Kokhreidze, MD study director
Spectrum Pharmaceuticals, Inc
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 Poziotinib Hydrochloride and Loperamide in people with Breast Cancer and Colorectal Cancer, run by Spectrum Pharmaceuticals, Inc 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 14 inclusion and 13 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 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 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 168 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 13 Mar 2024.