MelanomaPhase 1NCT03272464
INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.
A Phase 1 study testing Trametinib, Dabrafenib and INCB039110 in people with Melanoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma. The drugs involved in this study are: Itacitinib (INCB039110) Dabrafenib Trametinib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Trametinib, Dabrafenib and INCB039110
- 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
- 29 May 2019to 27 Dec 2019
- Phase
- Phase 1
- 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
- For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective.
- If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided to the Overall Principal Investigator (PI) for approval. (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test).
- For Dose-Expansion Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy.
- If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided to the Overall Principal Investigator (PI) for approval. (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test).
- Patients must have measurable disease by RECIST, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Patients may have received any number of prior lines of therapy. All prior systemic anti-cancer treatment-related toxicities must be less than or equal to Grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0; NCI, 2009) at the time of enrollment. This does not include alopecia and Grade 2 or less peripheral neuropathy.
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- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of INCB039110 in combination with dabrafenib and trametinib in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).
- Life expectancy of greater than 3 months in the opinion of the investigator.
- Patients must have acceptable organ and marrow function as defined below:
- Leukocytes (WBCs) ≥3,000/uL
- absolute neutrophil count ≥1,500/uL
- hemoglobin > 9 g/dl (patients may be transfused to this level)
- platelets ≥ 100,000/uL
- total bilirubin < 1.5 x institutional upper limit of normal OR > 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range.
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal
- PT/INR and PTT < 1.3 x ULN1
- Serum creatinine ≤1.5 mg/dL OR creatinine clearance ≥50 mL/min/1.73 m2
- Potassium >3 and <5.5mmol/L
- Magnesium >1.2 and <2.5 mg/dL
- 1Therapeutic levels of anti-coagulation are permitted if clinically indicated, as per section 3.2.15. Thus PT/INR may be >1.3 if therapeutically anti-coagulated.
- The effects of INCB039110, dabrafenib, and trametinib on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed due to drug-drug interactions which can render hormonal contraceptives ineffective) from 14 days prior to registration, throughout the treatment period, and for 4 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- Based on studies in animals, it is also known that dabrafenib may cause damage to the tissue that makes sperm. This may cause sperm to be abnormal in shape and size and could lead to infertility, which may be irreversible.
- Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception. Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 4 months following completion of therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Able to swallow and retain oral medication, and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Who cannot join
- Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiotherapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to Day 1 of Cycle 1. Patients are permitted to be on dabrafenib and trametinib at start of therapy without wash-out period prior to Day 1 of Cycle 1. Dosing will change to protocol determined dose levels on Day 1 of Cycle 1
- Patients must not have received prior JAK1 inhibitor therapy.
- Patients who are receiving any other investigational agents. Patients who have taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to registration.
- Patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study. Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
- Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic, untreated, not stable for ≥ 4 weeks prior to Day 1 of Cycle 1 (must be documented by imaging), or requiring corticosteroids to manage metastasis-related symptoms. Subjects who have been off of corticosteroids for at least 2 weeks prior to Day 1 of Cycle 1 or are on a stable dose of ≤10 mg per day of a prednisone equivalent for >1 month prior to Day 1 of Cycle 1 can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for >4 weeks prior to Day 1 of Cycle 1.
- History of known immediate or delayed hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to INCB039110, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO).
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because INCB039110, dabrafenib, and trametinib may have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the mother being treated with the study drugs.
- History of interstitial lung disease or pneumonitis.
- Patients known to be HIV-positive patients and on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
- History or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED):
- History of RVO or RPED, or predisposing factors to RVO or RPED (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
- Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure >21 mm Hg.
- History or evidence of cardiovascular risk including any of the following:
- A QT interval corrected for heart rate using the Bazett's formula QTcB ≥460 msec on the pre-study baseline single 12 lead EKG.
- History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for >30 days prior to registration are eligible).
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to registration.
- History or evidence of current ≥ Class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
- Treatment-refractory hypertension defined as a blood pressure of systolic >140 mmHg and/or diastolic >90 mmHg which cannot be controlled by anti-hypertensive therapy. In patients with no history of hypertension and a pre-study baseline blood pressure of systolic >140 mmHg and/or diastolic >90 mmHg, a second reading should be taken at least 1 minute later, with the two readings averaged to obtain a final BP measurement.
- Abnormal cardiac valve morphology (≥grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
- Prior placement of an implantable defibrillator
- History of or identification on screening imaging of intracardiac metastases
- No known active infection with Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV). Patients with chronic or cleared HBV infection and HCV infection are eligible.
- For patients requiring anti-coagulation with vitamin K antagonists, therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site. Exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR. Consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate. If clinically indicated, prophylactic low dose warfarin may be given to maintain central catheter patency.
- Current use of a prohibited medication. The following medications or non-drug therapies are prohibited
- Other anti-cancer therapy while on study treatment. (note: megestrol [Megace] if used as an appetite stimulant is allowed).
- Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy. Prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis.
- Because the composition, PK, and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng).
- Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible. Current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Official title: Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.
This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma.
The drugs involved in this study are:
- Itacitinib (INCB039110)
- Dabrafenib
- Trametinib
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of the investigational drugs and also tries to define the appropriate doses of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved itacitinib as a treatment for any disease.
The FDA has approved dabrafenib and trametinib as a treatment option for Melanoma.
In this research study, the investigators are studying the combination of itacitinib, dabrafenib, and trametinib. The investigators believe this combination of study drugs may stop the participant's cancer cells from growing and spreading. All three of the study drugs are inhibitors. Trametinib may work by binding to the participant's cancer cells to inhibit the cancer cells' signals to decrease cell growth, dabrafenib may work by stopping the participant's cancer cells from duplicating, and itacitinib may work by stopping the participant's tumor cells from living and growing.
- Conditions
- Melanoma
- Being tested
- Trametinib, Dabrafenib, INCB039110
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
Also called Mekinist
Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth.
DabrafenibDrug
Also called Tafinlar
Dabrafenib may work by stopping your cancer cells from duplicating.
INCB039110Drug
Also called Itacitinib
Itacitinib may work by stopping your tumor cells from living and growing.
| Study group | Role | What they receive |
|---|---|---|
| Trametinib + Dabrafenib + INCB039110 | Experimental | * Dabrafenib is administered orally every 12 hours
* Trametinib is administered orally once a day
* INCB039110 is administered orally once a day Receives: Drug: Trametinib; Drug: Dabrafenib; Drug: INCB039110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Maximum tolerated dose (MTD) is defined as the highest dose of the treatment that does not cause unacceptable side effects in at least two-thirds of participants.
Measured: Approximately 2 months
Secondary outcomes (3)
Objective Response Rate
Objective response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1 criteria as their best response to therapy.
Measured: Approximately 7 months
Number of Participants With Progression-Free Survival at 6 Months
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: 6 Months
Overall Survival
Overall Survival (OS) is defined as the time from the first treatment date to death due to any cause, or censored at date last known alive.
Measured: approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start29 May 2019
- Primary completion24 Jul 2019
- Study completion27 Dec 2019
Why it stopped: Slow accrual
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 MelanomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, David M. Miller, M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- David M. Miller, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272464
- Sponsor's protocol ID
- 17-380
- Status last verified
- Nov 2022
- First submitted
- 1 Sep 2017
- Last updated
- 22 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.
- ClinicalTrials.gov ID
- NCT03272464
- Acronym / sponsor ID
- 17-380
- Conditions
- Melanoma
- Keywords
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 29 May 2019 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma.
The drugs involved in this study are:
- Itacitinib (INCB039110)
- Dabrafenib
- Trametinib
Detailed description
This research study is a Phase I clinical trial, which tests the safety of the investigational drugs and also tries to define the appropriate doses of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved itacitinib as a treatment for any disease.
The FDA has approved dabrafenib and trametinib as a treatment option for Melanoma.
In this research study, the investigators are studying the combination of itacitinib, dabrafenib, and trametinib. The investigators believe this combination of study drugs may stop the participant's cancer cells from growing and spreading. All three of the study drugs are inhibitors. Trametinib may work by binding to the participant's cancer cells to inhibit the cancer cells' signals to decrease cell growth, dabrafenib may work by stopping the participant's cancer cells from duplicating, and itacitinib may work by stopping the participant's tumor cells from living and growing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trametinib + Dabrafenib + INCB039110 | Experimental | Drug: Trametinib, Drug: Dabrafenib, Drug: INCB039110* Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective.
- If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided to the Overall Principal Investigator (PI) for approval. (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test).
- For Dose-Expansion Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy.
- If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided to the Overall Principal Investigator (PI) for approval. (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test).
- Patients must have measurable disease by RECIST, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
Key exclusion criteria (30 listed)
- Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiotherapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to Day 1 of Cycle 1. Patients are permitted to be on dabrafenib and trametinib at start of therapy without wash-out period prior to Day 1 of Cycle 1. Dosing will change to protocol determined dose levels on Day 1 of Cycle 1
- Patients must not have received prior JAK1 inhibitor therapy.
- Patients who are receiving any other investigational agents. Patients who have taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to registration.
- Patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study. Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
- Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic, untreated, not stable for ≥ 4 weeks prior to Day 1 of Cycle 1 (must be documented by imaging), or requiring corticosteroids to manage metastasis-related symptoms. Subjects who have been off of corticosteroids for at least 2 weeks prior to Day 1 of Cycle 1 or are on a stable dose of ≤10 mg per day of a prednisone equivalent for >1 month prior to Day 1 of Cycle 1 can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for >4 weeks prior to Day 1 of Cycle 1.
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 |
|---|---|---|
| TrametinibAlso: MekinistTrametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. | Drug | Trametinib + Dabrafenib + INCB039110 |
| DabrafenibAlso: TafinlarDabrafenib may work by stopping your cancer cells from duplicating. | Drug | Trametinib + Dabrafenib + INCB039110 |
| INCB039110Also: ItacitinibItacitinib may work by stopping your tumor cells from living and growing. | Drug | Trametinib + Dabrafenib + INCB039110 |
Primary outcome
Maximum Tolerated Dose
Time frame: Approximately 2 months
Maximum tolerated dose (MTD) is defined as the highest dose of the treatment that does not cause unacceptable side effects in at least two-thirds of participants.
3 secondary outcomes
Objective Response Rate
Time frame: Approximately 7 months
Number of Participants With Progression-Free Survival at 6 Months
Time frame: 6 Months
Overall Survival
Time frame: approximately 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Miller, MD, PhD principal investigator
Massachusetts General Hospital
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 Trametinib, Dabrafenib and INCB039110 in people with Melanoma, run by Massachusetts General Hospital 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 30 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 22 Sep 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?
Yes. Results are posted in the registry (first posted 22 Sep 2023). 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?
Maximum Tolerated Dose (time frame: Approximately 2 months). 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 22 Sep 2023.