Metastatic Breast CancerPhase 1NCT01300962
Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer
A Phase 1 study testing BMK120, Capecitabine and BYL719 in people with Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This phase I study has been designed to establish the safety, tolerability and maximum tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer: dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and trastuzumab (Arm C), or with capecitabine and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- BMK120, Capecitabine and BYL719
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to 31 Dec 2018
- 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
None listed.
Who cannot join
- Subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:
- Receiving concurrent endocrine, cytotoxic, or biologic agent(s) or within time limits specified above prior to study day 1
- Receiving any other investigational agents currently, or within time limits specified above prior to study day 1
- Received wide field radiotherapy ≤4 weeks, or SRS or gamma knife for brain metastasis ≤ 2 weeks or limited field radiation for palliation ≤2 weeks prior to starting either BYL719 or BKM120 or have not recovered from side effects of such therapy
- Have undergone major surgery ≤2 weeks prior to starting BKM120 or BYL719 or have not recovered from side effects of such therapy
- Prior treatment with treatment doses of capecitabine (prior radio-sensitizing doses of capecitabine are allowed as long as the patient did not progress on capecitabine)
Show all 45Show fewer
- Prior treatment with a PI3K inhibitor
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
- Currently receiving treatment with medication known to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug
- Patients currently receiving chronic systemic treatment with steroids or another immunosuppressive agent; NOTE: This restriction regarding choice of glucocorticoid does not apply should patient need <2 week course of glucocorticoid for treatment of non-infectious pneumonitis during study, or if ARM C patient with brain metastases treated with glucocorticoid is enrolled. Topical applications (e.g., rash), inhaled sprays, eye drops or local injections of steroids are allowed.
- Known coagulopathies, and those who require therapeutic anticoagulation with coumarin-derivative anticoagulants
- Presence of acute or chronic liver, renal disease, or pancreatitis
- For all Arms, patients with poorly controlled diabetes mellitus, and/or with clinical signs, and/or steroid-induced diabetes mellitus; for Arm B, patients requiring insulin treatment
- History of gestational diabetes mellitus
- Known diagnosis of human immunodeficiency virus (HIV) infection
- For Arms A, C or D, patients with the following mood disorders as judged by the investigator or a psychiatrist, or as result of patient's mood assessment questionnaire:
- Medically documented history of major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or patients with active severe personality disorders (defined according to DSM-IV). NOTE: for patients with psychotropic treatments ongoing at baseline, the dose and schedule should not be modified within the previous 6 weeks prior to D1 of treatment with BKM120
- ≥ CTCAE grade 3 anxiety
- At screening, meets the cut-off score of ≥10 in the Patient Health Questionnaire (PHQ-9) or a cut-off of ≥ 15 in the Generalized Anxiety Disorder (GAD-7) mood scale, respectively, or selects a positive response of 1, 2 or 3 to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study unless overruled by the psychiatric assessment
- Note: The psychiatric judgment overrules the mood assessment questionnaire result/investigator's judgment.
- Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, Seville oranges, pummelos, and exotic citrus fruits from 7 days prior to the dose of study medication and during the entire study due to potential CYP3A4 interaction with the study medication. Orange juice is allowed
- Intake of any herbal preparations or medications (e.g., including, but not limited to, Saint-Johns Wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drug
- For ARMS A, C and D, unable or unwilling to discontinue use of any drug known to be a strong or moderate inhibitor or inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to first dose of study drug) (see Appendix B); please note that co-treatment with weak inhibitors of CYP3A4 is allowed.
- Patients who received live vaccines or who have close contact with people who have received live vaccines within 7 days of day 1 of study treatment (see Appendix B)
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 or BYL719 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection); Patients with unresolved diarrhea will be excluded.
- Inadequately controlled hypertension (i.e. SBP >180 mmHg or DBP >100mmHg)
- Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- Left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Grated acquisition (MUGA) scan or echocardiogram (ECHO)
- ST depression or elevation of ≥1.5 mm in 2 or more leads
- Congenital long QT syndrome
- History or presence of ventricular arrhythmias or atrial fibrillation
- Clinically significant resting bradycardia (<50 beats per minutes)
- QTc >480 msec on screening ECG
- Complete left bundle branch block
- Right bundle branch block + left anterior hemiblock (bifascicular block)
- Unstable angina pectoris ≤6 months prior to starting study drug
- Acute myocardial infarction ≤6 months prior to starting study drug
- Other clinically significant heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA] Class III or IV)
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
- Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, 02 saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
- Prior malignancy Exceptions: Subjects who have had another malignancy and have been disease-free for 3 years or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
- History of allergic reactions attributed to compounds of similar chemical or biologic composition of BKM120, BYL719, capecitabine (including fluorouracil), trastuzumab or lapatinib
- Pregnant or lactating women
- Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: A Four Part, Phase I Dose-Escalation Study of the Combinations of Concurrent BKM120 and Capecitabine, or Concurrent BYL719 and Capecitabine, or Concurrent BKM120 and Capecitabine and Trastuzumab, or Concurrent BKM120 and Capecitabine and Lapatinib in Patients With Metastatic Breast Cancer
This phase I study has been designed to establish the safety, tolerability and maximum tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer: dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235 when combined with capecitabine (Arm B).
Read the detailed description
STUDY OBJECTIVES Primary Objectives
- To determine the safety, DLT, and MTD of BKM120 when administered concomitantly with capecitabine in patients with metastatic breast cancer (ARM A)
- To determine the safety, DLT, and MTD of BYL719 when administered concomitantly with capecitabine in patients with metastatic breast cancer (ARM B)
- To determine the safety, DLT, and MTD of BKM120 when administered concomitantly with capecitabine and trastuzumab in patients with metastatic breast cancer (ARM C)
- To determine the safety, DLT, and MTD of BKM120 when administered concomitantly with capecitabine and lapatinib in patients with metastatic breast cancer (ARM D)
Secondary Objectives
- To characterize the safety and tolerability of BKM120 in combination with capecitabine including acute and chronic toxicities
- To characterize the safety and tolerability ofBYL719 in combination with capecitabine including acute and chronic toxicities
- To characterize the safety and tolerability of BKM120 in combination with capecitabine and trastuzumab, including acute and chronic toxicities
- To characterize the safety and tolerability of BKM120 in combination with capecitabine and lapatinib, including acute and chronic toxicities
Exploratory Objectives
- To obtain primary, archived paraffin-embedded tissues to evaluate intrinsic breast cancer subtype (i.e., HER2, luminal B, etc.) and other important predictive biomarkers (PI3K activating mutations, pAKT, p-mTOR), and explore correlations with therapeutic response to BKM120 or BYL719 in combination with capecitabine, with or without the addition of lapatinib or trastuzumab
- To evaluate the PK profile of BKM120 with concomitant capecitabine
- To examine other signaling pathway signatures
- To examine drug effect in pre- and post-treatment core biopsy specimens (optional) from appropriate patients
- To explore patient motivators for enrolling in early phase studies through patient interview
Outline:
This study is a four-arm multi-center, open-label phase I clinical trial testing the hypothesis that the addition of BKM120 to capecitabine (ARM A); the addition of BYL719 to capecitabine (ARM B); the addition of BKM120 to capecitabine plus trastuzumab (ARM C); or the addition of BKM120 to capecitabine plus lapatinib (ARM D) will be safe and tolerable as evidenced by the DLT seen. Following screening and informed consent, treatment will be initiated with one of the following:
ARM A: BKM120 PO daily for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week).
ARM B: BYL719 PO BID for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week of the cycle)
ARM C: BKM120 PO daily for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week) plus trastuzumab by intravenous infusion on Day 1
ARM D: BKM120 PO daily for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week) plus lapatinib PO daily for 21 days.
The consents are separate documents and the patient and the study team know ahead of time which Arm is open and enrolling and can therefore focus their discussion with the patient on that ARM.
Cycles in each arm will be repeated every 3 weeks (21 days). Patients will continue on protocol-based therapy until progression, unacceptable toxicity, study withdrawal, or patient death.
- Conditions
- Metastatic Breast Cancer
- Being tested
- BMK120, Capecitabine, BYL719, Trastuzumab, Lapatinib
- Keywords
- Xeloda, Capecitabine, BKM120, Lineberger Comprehensive Cancer Center, Metastatic, BYL719 Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMK120Drug
BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death.
CapecitabineDrug
Also called Xeloda
875-1250mg/m2 PO BID for two weeks followed by one week rest every three week cycle. Number of cycles: until progression of disease, unacceptable toxicity, withdrawal or death.
BYL719Drug
BYL719 200mg PO BID for 21 days (3 weeks) in combination with capecitabine 1000 mg/m2 PO BID for 2 weeks
TrastuzumabDrug
Also called Herceptin
trastuzumab infusion on day 1 of each cycle.
LapatinibDrug
Also called Tykerb
lapatinib daily for 21 days in each cycle.
| Study group | Role | What they receive |
|---|---|---|
| BYL719 ARM B | Experimental | Treatment with BYL719 and Capecitabine Receives: Drug: Capecitabine; Drug: BYL719 |
| BKM120 ARM A | Experimental | Treatment with BKM120 and capecitabine Receives: Drug: BMK120; Drug: Capecitabine |
| ARM C | Experimental | BKM 120 plus capecitabine plus trastuzumab Receives: Drug: BMK120; Drug: Capecitabine; Drug: Trastuzumab |
| ARM D | Experimental | BKM120 plus capecitabine plus lapatinib Receives: Drug: BMK120; Drug: Capecitabine; Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Maximum Tolerated Dose (MTD) will be the highest does at which less than or equal to 1 out of 6 patients have experienced a dose limiting toxicity (DLT)
Measured: two years
Dose limiting toxicity (DLT)
Dose-limiting toxicities (DLT) will be defined per NCI Common Terminology Criteria for Adverse Events version 4 (CTCAE v4)
Measured: two years
Secondary outcomes (2)
Objective Response
Objective response is measured by assessing the tumor response using Recist 1.1 criteria
Measured: two years
Best Overall Response
The best overall response is defined as the best response achieved across all time points prior to progression (for example, a patient who has SD at first assessment, PR at second assessment, and PD on last assessment has a best overall response of PR).
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startAug 2011
- Primary completion7 Feb 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Claire Dees, Principal investigator, University of North Carolina Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300962
- Sponsor's protocol ID
- LCCC 1024
- Other IDs
- 11-0060
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2011
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Part, Phase I Dose-Escalation Study of the Combinations of Concurrent BKM120 and Capecitabine, or Concurrent BYL719 and Capecitabine, or Concurrent BKM120 and Capecitabine and Trastuzumab, or Concurrent BKM120 and Capecitabine and Lapatinib in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01300962
- Acronym / sponsor ID
- LCCC 1024
- Conditions
- Metastatic Breast Cancer
- Keywords
- Xeloda, Capecitabine, BKM120, Lineberger Comprehensive Cancer Center, Metastatic, BYL719 Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Aug 2011
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Feb 2011 (estimated)
- 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 study has been designed to establish the safety, tolerability and maximum tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer: dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235 when combined with capecitabine (Arm B).
Detailed description
STUDY OBJECTIVES Primary Objectives
- To determine the safety, DLT, and MTD of BKM120 when administered concomitantly with capecitabine in patients with metastatic breast cancer (ARM A)
- To determine the safety, DLT, and MTD of BYL719 when administered concomitantly with capecitabine in patients with metastatic breast cancer (ARM B)
- To determine the safety, DLT, and MTD of BKM120 when administered concomitantly with capecitabine and trastuzumab in patients with metastatic breast cancer (ARM C)
- To determine the safety, DLT, and MTD of BKM120 when administered concomitantly with capecitabine and lapatinib in patients with metastatic breast cancer (ARM D)
Secondary Objectives
- To characterize the safety and tolerability of BKM120 in combination with capecitabine including acute and chronic toxicities
- To characterize the safety and tolerability ofBYL719 in combination with capecitabine including acute and chronic toxicities
- To characterize the safety and tolerability of BKM120 in combination with capecitabine and trastuzumab, including acute and chronic toxicities
- To characterize the safety and tolerability of BKM120 in combination with capecitabine and lapatinib, including acute and chronic toxicities
Exploratory Objectives
- To obtain primary, archived paraffin-embedded tissues to evaluate intrinsic breast cancer subtype (i.e., HER2, luminal B, etc.) and other important predictive biomarkers (PI3K activating mutations, pAKT, p-mTOR), and explore correlations with therapeutic response to BKM120 or BYL719 in combination with capecitabine, with or without the addition of lapatinib or trastuzumab
- To evaluate the PK profile of BKM120 with concomitant capecitabine
- To examine other signaling pathway signatures
- To examine drug effect in pre- and post-treatment core biopsy specimens (optional) from appropriate patients
- To explore patient motivators for enrolling in early phase studies through patient interview
Outline:
This study is a four-arm multi-center, open-label phase I clinical trial testing the hypothesis that the addition of BKM120 to capecitabine (ARM A); the addition of BYL719 to capecitabine (ARM B); the addition of BKM120 to capecitabine plus trastuzumab (ARM C); or the addition of BKM120 to capecitabine plus lapatinib (ARM D) will be safe and tolerable as evidenced by the DLT seen. Following screening and informed consent, treatment will be initiated with one of the following:
ARM A: BKM120 PO daily for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week).
ARM B: BYL719 PO BID for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week of the cycle)
ARM C: BKM120 PO daily for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week) plus trastuzumab by intravenous infusion on Day 1
ARM D: BKM120 PO daily for 21 days (3 weeks) plus capecitabine PO BID for 2 weeks (no capecitabine is administered during the third week) plus lapatinib PO daily for 21 days.
The consents are separate documents and the patient and the study team know ahead of time which Arm is open and enrolling and can therefore focus their discussion with the patient on that ARM.
Cycles in each arm will be repeated every 3 weeks (21 days). Patients will continue on protocol-based therapy until progression, unacceptable toxicity, study withdrawal, or patient death.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BYL719 ARM B | Experimental | Drug: Capecitabine, Drug: BYL719Treatment with BYL719 and Capecitabine |
| BKM120 ARM A | Experimental | Drug: BMK120, Drug: CapecitabineTreatment with BKM120 and capecitabine |
| ARM C | Experimental | Drug: BMK120, Drug: Capecitabine, Drug: TrastuzumabBKM 120 plus capecitabine plus trastuzumab |
| ARM D | Experimental | Drug: BMK120, Drug: Capecitabine, Drug: LapatinibBKM120 plus capecitabine plus lapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (45 listed)
- Subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:
- Receiving concurrent endocrine, cytotoxic, or biologic agent(s) or within time limits specified above prior to study day 1
- Receiving any other investigational agents currently, or within time limits specified above prior to study day 1
- Received wide field radiotherapy ≤4 weeks, or SRS or gamma knife for brain metastasis ≤ 2 weeks or limited field radiation for palliation ≤2 weeks prior to starting either BYL719 or BKM120 or have not recovered from side effects of such therapy
- Have undergone major surgery ≤2 weeks prior to starting BKM120 or BYL719 or have not recovered from side effects of such therapy
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 |
|---|---|---|
| BMK120BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death. | Drug | ARM C, ARM D, BKM120 ARM A |
| CapecitabineAlso: Xeloda875-1250mg/m2 PO BID for two weeks followed by one week rest every three week cycle. Number of cycles: until progression of disease, unacceptable toxicity, withdrawal or death. | Drug | ARM C, ARM D, BKM120 ARM A, BYL719 ARM B |
| BYL719BYL719 200mg PO BID for 21 days (3 weeks) in combination with capecitabine 1000 mg/m2 PO BID for 2 weeks | Drug | BYL719 ARM B |
| TrastuzumabAlso: Herceptintrastuzumab infusion on day 1 of each cycle. | Drug | ARM C |
| LapatinibAlso: Tykerblapatinib daily for 21 days in each cycle. | Drug | ARM D |
Primary outcome
Maximum Tolerated Dose
Time frame: two years
Maximum Tolerated Dose (MTD) will be the highest does at which less than or equal to 1 out of 6 patients have experienced a dose limiting toxicity (DLT)
Dose limiting toxicity (DLT)
Time frame: two years
Dose-limiting toxicities (DLT) will be defined per NCI Common Terminology Criteria for Adverse Events version 4 (CTCAE v4)
2 secondary outcomes
Objective Response
Time frame: two years
Best Overall Response
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
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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.
Claire Dees principal investigator
University of North Carolina Lineberger Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMK120, Capecitabine and BYL719 in people with Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 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 0 inclusion and 45 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: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (time frame: two 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 4 Dec 2023.