Solid Tumor, ChildhoodPhase 1NCT03936465
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
A Phase 1 study testing BMS-986158 and BMS-986378 in people with Solid Tumor, Childhood and Lymphoma, run by Dana-Farber Cancer Institute at 6 sites in 2 countries.
Trial summary
Arm 1 of this research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors or lymphoma. Arm 2 of this research study is studying an investigational drug called BMS-986378 (also known as CC-90010) as a possible treatment for pediatric brain tumors or pediatric… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Solid Tumor, Childhood, Lymphoma, Brain Tumor, Pediatric
- What is being tested?
- BMS-986158 and BMS-986378
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 27 Sep 2019to 1 Oct 2024
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≤ 21 years at time of enrollment. Note the requirement in section 3.1.6 that all patients must be able to swallow intact capsules.
- Karnofsky performance status ≥ 50% for patients ≥16 years of age or Lansky ≥ 50% for patients <16 years of age (see Appendix A)
- Diagnosis requirement
- Participants must have evaluable or measurable disease (see Section 11).
- Must have disease that is relapsed or refractory and for which standard curative measures do not exist or are no longer effective.
- For Arm 1, Cohort 1A, participants must have histologically confirmed non-CNS primary solid tumors or lymphoma based upon biopsy or surgery at relapse/progression. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
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- For Arm 1, Cohort 1B, participants must have histologically confirmed solid tumors or lymphoma based upon biopsy or surgery at relapse/progression as well as documentation of one of the following confirmed tumor molecular features obtained in a laboratory certified to return results for clinical purposes. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
- MYCN amplification or high copy number gain
- MYC amplification or high copy number gain
- Translocation involving MYC or MYCN
- Translocation involving BRD4 or BRD3
- BRD4 amplification or high copy number gain
- Histologic diagnosis of NUT midline carcinoma
- For Arm 2, Cohort 2A, participants must have histologically confirmed primary CNS p tumors or untreated CNS metastases based upon biopsy or surgery at relapse/progression. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
- For Arm 2, Cohort 2B, participants must have histologically confirmed primary CNS p tumors or untreated CNS metastases based upon biopsy or surgery at relapse/progression as well as documentation of one of the following confirmed tumor molecular features obtained in a laboratory certified to return results for clinical purposes. Patients without biopsy or surgery at relapse/progression and with tissue only available from initial diagnosis may still be considered after discussion with the overall Primary Investigator.
- MYCN amplification or high copy number gain
- MYC amplification or high copy number gain
- Translocation involving MYC or MYCN
- Translocation involving BRD4 or BRD3
- BRD4 amplification or high copy number gain
- Histologic diagnosis of NUT midline carcinoma
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted in Section 3.1.5. Patients must meet the following minimum washout periods prior to enrollment:
- Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C).
- Radiotherapy:
- At least 14 days after local XRT (small port, including cranial radiation);
- At least 90 days must have elapsed after prior TBI, or if >50% radiation of pelvis;
- At least 180 days must have elapsed after prior craniospinal XRT;
- At least 42 days must have elapsed if other substantial BM radiation;
- At least 42 days must have passed since last MIBG or other radionuclide therapy.
- Small molecule biologic therapy: At least 7 days following the last dose of a small molecule biologic agent. For agents with known adverse events occurring beyond 7 days, this duration must be extended beyond the time in which adverse events are known to occur. If extended duration is required, this must be discussed with and approved by the overall PI.
- Monoclonal antibody: At least 28 days must have elapsed after the last dose of therapeutic monoclonal antibody.
- Myeloid growth factors: At least 14 days following the last dose of long-acting growth factor (e.g. Neulasta) or 7 days following short-acting growth factor.
- Autologous hematopoietic stem cell transplant and stem cell boost: Patients must be at least 60 days from day 0 of an autologous stem cell transplant or autologous stem cell boost.
- Cellular therapies (including CAR-T cells) and other non-cellular, non-antibody immunotherapies (e.g., vaccines): At least 42 days must have elapsed after last dose.
- Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Major surgical procedure will be considered all surgical procedures aside from the following: Biopsy; central line placement/removal; bone marrow aspirate/biopsy; lumbar puncture; dental procedures; gastrostomy tube placement; and VP shunt placement/revision.
- BET inhibitors: Patients must not have received prior treatment with a BET inhibitor, except patients with CNS tumors or CNS metastasis previously treated on Arm 1 of the trial who discontinued protocol therapy due to disease progression and not due to toxicity. Such patients may participate in Arm 2 of the trial.
- Participants must have normal organ function as defined below.
- Bone Marrow Function
- For Patients without Documented Bone Marrow Involvement by Disease:
- Hemoglobin > 8 g/dL (may be transfused)
- Absolute neutrophil count ≥ 1,000 /uL
- Platelets ≥ 100,000 /uL and transfusion independent, defined as not receiving a platelet transfusion for at least 5 days prior to CBC documenting eligibility.
- For Patients with Documented Bone Marrow Involvement by Disease:
- Hemoglobin > 8 g/dL (may be transfused)
- Absolute neutrophil count ≥ 750 /uL
- Platelets ≥ 75,000 /uL and transfusion independent, defined as not receiving a platelet transfusion for at least 5 days prior to CBC documenting eligibility.
- Hepatic Function:
- Total bilirubin ≤ 1.5 x upper limit of normal for age (patients with known Gilbert's may be considered after discussion with overall PI and if direct bilirubin is at or below the upper limit of normal for age)
- ALT (SGPT) ≤ 3 x upper limit of normal (135 U/L) For the purpose of this study, the ULN for ALT is 45 U/L
- Serum albumin > 2 g/dL
- Adequate Pancreatic Function:
- --Lipase < upper limit of normal
- Adequate GI Function:
- --Diarrhea < grade 1 by CTCAE version 5
- Coagulation Factors:
- International Normalized Ratio (INR) < 1.5
- Partial thromboplastin time (PTT) < 1.5 times upper limit of normal
- For patients having labs drawn via heparinized catheters, it is important to request heparin-absorbed values.
- Adequate Cardiac Function:
- --QTc < 480 msec
- Renal Function:
- A serum creatinine within protocol limits based on age/sex.
- OR
- Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels greater than the above age/sex maximum allowed values.
- Able to swallow intact capsules (BMS-986158) or tablets (BMS-986378, also known as CC-90010).
- Patient (or parent or legally authorized representative, if minor) is able to understand and willing to provide informed consent, using an institutionally approved informed consent procedure.
- Participants of childbearing or child-fathering potential must agree to use adequate contraception throughout their participation following the guidance in Appendix H.
Who cannot join
- Prior solid organ or allogeneic stem cell transplantation.
- Patients with primary or metastatic CNS tumors are not eligible for Arm 1, except:
- --Patients with a history of CNS metastatic disease that has been resected and/or radiated without evidence of active CNS disease for 3 months preceding enrollment; NOTE: patients with primary CNS tumors or solid tumors with active CNS metastases will be eligible for Arm 2.
- Patients receiving any of the following prohibited foods and medications:
- Agents listed in Appendix B within 7 days prior to enrollment
- Grapefruit or Seville oranges and/or their juices within 7 days prior to enrollment
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- Non-steroidal anti-inflammatory drugs, oral anticoagulants, and therapeutic heparins (unfractionated or low molecular weight heparin) at the time of enrollment. Note: Use of heparin to maintain patency of a central or peripheral catheter is allowed
- Other investigational agents being administered under an IND.
- Pregnant participants will not be entered on this study given that the effects of BMS-986158 and BMS-986378 (CC-90010) on the developing human fetus are unknown. Female participants of childbearing potential must have a documented negative pregnancy exam within 24 hours prior to dosing.
- Breastfeeding mothers are not eligible, because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with BMS-986158 or BMS-986378 (CC-90010).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BMS-986158 or BMS-986378 (CC-90010).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with a known history of HIV, hepatitis B, and/or hepatitis C (testing not required as part of screening).
- Patients with gastrointestinal disease or disorder that could interfere with absorption of BMS-986158 or BMS-986378 (CC-90010), such as bowel obstruction or inflammatory bowel disease.
- For Arm 1: Patients with BSA < 0.3 m2 for all dose levels except Dose Level -2 or -2i for which patients with BSA < 0.71 m2 will be excluded due to dose rounding constraints.
- For Arm 2: Patients with BSA < 0.65 m2.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Phase 1 Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 (CC-90010) in Pediatric Cancer
Arm 1 of this research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors or lymphoma. Arm 2 of this research study is studying an investigational drug called BMS-986378 (also known as CC-90010) as a possible treatment for pediatric brain tumors or pediatric tumors that have spread to the brain.
Read the detailed description
This is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved BMS-986158 or BMS-986378 as a treatment for any disease.
BMS-986158 and BMS-986378 are currently still being studied in adults. This is the first time that BMS-986158 or BMS-986378 will be evaluated in younger children, though children 12-17 years of age may also be included in parts of adult studies of BMS-986158.
Research in the laboratory has shown that BMS-986158 and BMS-986378 may have activity against cancer cells. These drugs belong to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
- Conditions
- Solid Tumor, Childhood, Lymphoma, Brain Tumor, Pediatric
- Being tested
- BMS-986158, BMS-986378
- Keywords
- Solid Tumor, Lymphoma, Neuroblastoma, Sarcoma, Medulloblastoma, MYC, MYCN, BRD4, BET inhibitor, Bromodomain
- Medical subject headings
- Lymphoma, Brain Neoplasms, Neuroblastoma, Sarcoma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986158Drug
BMS-986158 belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
BMS-986378Drug
Also called CC-90010
BMS-986378 (also known as CC-90010) belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Cohort A | Experimental | * Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles.
* Patients with unselected relapsed or refractory solid tumors or lymphoma Receives: Drug: BMS-986158 |
| Arm 1 Cohort B | Experimental | * Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles.
* Patients with relapsed or refractory solid tumors or lymphoma that have defined molecular features predicted to increase sensitivity to BET inhibition Receives: Drug: BMS-986158 |
| Arm 2 Cohort A | Experimental | * Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days.
* Patients with relapsed or refractory CNS tumors or CNS metastatic tumors Receives: Drug: BMS-986378 |
| Arm 2 Cohort B | Experimental | * Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days.
* Patients with relapsed or refractory CNS tumors or CNS metastatic tumors that have defined molecular features predicted to increase sensitivity to BET inhibition Receives: Drug: BMS-986378 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity Rate
Dose limiting toxicity as defined in protocol
Measured: 28 days (first cycle)
The Rate of Toxicities from Protocol Therapy
Adverse events coded using CTCAE version 5
Measured: 2 years
Secondary outcomes (6)
Objective Response Rate
Objective response rate
Measured: 2 years
Pharmacokinetics of BMS-986158 (Arm 1) or BMS-986378 (Arm 2)
Plasma concentrations of BMS-986158 or BMS-986378
Measured: 2 years
Pharmacodynamics of BMS-986158 (Arm 1) or BMS-986378 (Arm 2)
Gene expression levels in peripheral blood
Measured: 2 years
Blood Markers of Response
Levels of ctDNA in peripheral blood
Measured: 2 years
CSF Markers of Response
Levels of ctDNA in CSF
Measured: 2 years
Tumor Markers of Response
Levels of Myc proteins in tumor
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start27 Sep 2019
- Primary completion16 Mar 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, ChildhoodStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stand Up To Cancer
- Responsible party
- Principal investigator, Steven DuBois, MD, Dana-Farber Cancer Institute
- Investigators
- Steven G. DuBois, MD, MS, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936465
- Sponsor's protocol ID
- 19-040
- Status last verified
- Oct 2024
- First submitted
- 30 Apr 2019
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 (CC-90010) in Pediatric Cancer
- ClinicalTrials.gov ID
- NCT03936465
- Acronym / sponsor ID
- 19-040
- Conditions
- Solid Tumor, Childhood, Lymphoma, Brain Tumor, Pediatric
- Keywords
- Solid Tumor, Lymphoma, Neuroblastoma, Sarcoma, Medulloblastoma, MYC, MYCN, BRD4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Stand Up To Cancer
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 3 May 2019 (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.
Arm 1 of this research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors or lymphoma. Arm 2 of this research study is studying an investigational drug called BMS-986378 (also known as CC-90010) as a possible treatment for pediatric brain tumors or pediatric tumors that have spread to the brain.
Detailed description
This is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved BMS-986158 or BMS-986378 as a treatment for any disease.
BMS-986158 and BMS-986378 are currently still being studied in adults. This is the first time that BMS-986158 or BMS-986378 will be evaluated in younger children, though children 12-17 years of age may also be included in parts of adult studies of BMS-986158.
Research in the laboratory has shown that BMS-986158 and BMS-986378 may have activity against cancer cells. These drugs belong to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Cohort A | Experimental | Drug: BMS-986158* Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles. * Patients with unselected relapsed or refractory solid tumors or lymphoma |
| Arm 1 Cohort B | Experimental | Drug: BMS-986158* Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles. * Patients with relapsed or refractory solid tumors or lymphoma that have defined molecular features predicted to increase sensitivity to BET inhibition |
| Arm 2 Cohort A | Experimental | Drug: BMS-986378* Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days. * Patients with relapsed or refractory CNS tumors or CNS metastatic tumors |
| Arm 2 Cohort B | Experimental | Drug: BMS-986378* Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days. * Patients with relapsed or refractory CNS tumors or CNS metastatic tumors that have defined molecular features predicted to increase sensitivity to BET inhibition |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (67 listed)
- Age ≤ 21 years at time of enrollment. Note the requirement in section 3.1.6 that all patients must be able to swallow intact capsules.
- Karnofsky performance status ≥ 50% for patients ≥16 years of age or Lansky ≥ 50% for patients <16 years of age (see Appendix A)
- Diagnosis requirement
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted in Section 3.1.5. Patients must meet the following minimum washout periods prior to enrollment:
- Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C).
Key exclusion criteria (16 listed)
- Prior solid organ or allogeneic stem cell transplantation.
- Patients with primary or metastatic CNS tumors are not eligible for Arm 1, except:
- --Patients with a history of CNS metastatic disease that has been resected and/or radiated without evidence of active CNS disease for 3 months preceding enrollment; NOTE: patients with primary CNS tumors or solid tumors with active CNS metastases will be eligible for Arm 2.
- Patients receiving any of the following prohibited foods and medications:
- Pregnant participants will not be entered on this study given that the effects of BMS-986158 and BMS-986378 (CC-90010) on the developing human fetus are unknown. Female participants of childbearing potential must have a documented negative pregnancy exam within 24 hours prior to dosing.
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 |
|---|---|---|
| BMS-986158BMS-986158 belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells. | Drug | Arm 1 Cohort A, Arm 1 Cohort B |
| BMS-986378Also: CC-90010BMS-986378 (also known as CC-90010) belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells. | Drug | Arm 2 Cohort A, Arm 2 Cohort B |
Primary outcome
Dose Limiting Toxicity Rate
Time frame: 28 days (first cycle)
Dose limiting toxicity as defined in protocol
The Rate of Toxicities from Protocol Therapy
Time frame: 2 years
Adverse events coded using CTCAE version 5
6 secondary outcomes
Objective Response Rate
Time frame: 2 years
Pharmacokinetics of BMS-986158 (Arm 1) or BMS-986378 (Arm 2)
Time frame: 2 years
Pharmacodynamics of BMS-986158 (Arm 1) or BMS-986378 (Arm 2)
Time frame: 2 years
Blood Markers of Response
Time frame: 2 years
CSF Markers of Response
Time frame: 2 years
Tumor Markers of Response
Time frame: 2 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 2 Oct 2024.
- 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.
Steven G. DuBois, MD, MS principal investigator
Dana-Farber Cancer Institute
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986158 and BMS-986378 in people with Solid Tumor, Childhood and Lymphoma, run by Dana-Farber Cancer Institute at 6 sites in 2 countries.
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 67 inclusion and 16 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
Dose Limiting Toxicity Rate (time frame: 28 days (first cycle)). 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 2 Oct 2024.