AMLPhase 1/2NCT04079738
Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
A Phase 1/2 study testing TAK-659 and Ixazomib in people with AML and AML, Adult, run by H Scott Boswell at 1 site in United States.
Trial summary
This is a Phase I/II study augmenting TAK-659 action in relapsed/refractory AML by addition of the proteasome inhibitor Ixazomib. Phase I of the study will determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of TAK-659 and Ixazomib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, AML, Adult
- What is being tested?
- TAK-659 and Ixazomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 23 Feb 2022
- Phase
- Phase 1/2
- 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
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Male or female patients 18 years or older at the time of consent.
- Patients must have a diagnosis of primary or secondary AML with relapsed or refractory disease (WHO update 2016, [34]) other than acute promyelocytic leukemia, or complex karyotype or monosomy 7 (or containing monosomy 7) for whom no standard therapies are anticipated to result in a durable remission according to the clinical judgment of the treating physician, or in a patient who refuses standard therapies.
- Must have submitted for Next Generation Sequencing (NGS) testing by: 1) (preferred) having submitted a tumor sample for commercial myeloid NGS from Foundation One, Mayo, Tempus, Quest, ARUP or an institutional CLIA-certified laboratory and/or 2) obtaining a bone marrow aspirate during screening for submission to Foundation One, Mayo, Tempus, Quest, ARUP or an institutional CLIA-certified laboratory and ordered as standard of care. If bone marrow aspiration has failed, a peripheral blood sample with circulating blasts may be substituted. Screening reports on tumor cytogenetics and/or mutation assays (eg, FLT-3, and NGS) performed as part of the standard of care will be recorded in the study database or obtained at the time of screening if not previously available.
- Patient's disease must be characterized for the presence/absence of Flt3ITD/TKD mutation from an FDA-approved vendor (ex. LabPMM).
- In addition, patients for the phase 2 portion of the study must meet the following:
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- Patients, if relapsed/ refractory, must have exposure to no more than 2 prior chemotherapy regimens. Re-induction with the same regimen or stem cell transplant will not be considered a separate regimen.
- Patients must not have prior exposure to any investigational Flt3 inhibitors (midostaurin or gilteritinib are allowed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of greater than 3 months as determined by the treating physician.
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, or
- Agree to practice true abstinence, when is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- Agree not to donate eggs (ova) during the course of this study or 180 days after receiving their last dose of study drug.
- Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and through 180 days after the last dose of study drug, or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception. Female and male condoms should not be used together.)
- Agree not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- In the absence of rapid progressive disease, the interval from prior systemic anticancer treatment to time of TAK-659/Ixazomib administration should be at least 2 weeks for cytotoxic agents (other than hydroxyurea), or at least 5 half-lives for noncytotoxic agents, and patients have to have recovered from acute toxicities of these therapies. Patients who are on hydroxyurea may be included in the study and may continue on hydroxyurea for the first 21 days while participating in this study. NOTE: For patients with a white blood cell count >50,000/uL, hydroxyurea may be used to control the level of circulating leukemic blast cell counts prior to study entry, and, if needed, concomitantly while on TAK-659 treatment during the first 21 days of the study.
- Suitable venous access for the study-required blood sampling, and transfusion support.
- Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Who cannot join
- Clinically active central nervous system leukemia.
- Female patients who are lactating and breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
- Female patients who have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
- Any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially jeopardize the safety of the patient or interfere with the objectives of the study.
- Prior treatment with investigational agents ≤ 21 days or ≤ 5 half-lives (whichever is shorter) before the first dose of study treatment. A minimum of 10 days should elapse from prior investigational therapy to initiating protocol therapy.
- Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher by the NCI CTCAE (v5).
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- Receipt of HSCT within 60 days of the first dose of TAK-659/Ixazomib; clinically significant graft-versus-host disease (GVHD) requiring ongoing immunosuppressive therapy post HSCT at the time of screening (use of topical steroids for ongoing skin GVHD is permitted).
- Active, systemic infection requiring intravenous (IV) antibiotic, antifungal, or antiviral therapy or other serious infection within 10 days before the first dose of study drug.
- Major surgery within 14 days before the first dose of study drug and have not recovered fully from any complications from surgery.
- Radiotherapy less than 2 weeks before the first dose of study treatment or have not recovered from acute toxic effects from radiotherapy.
- Known human immunodeficiency virus (HIV) positive.
- Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection (testing not required).
- Any of the following cardiovascular conditions:
- Acute myocardial infarction within 6 months before starting study drug.
- Current or history of New York Heart Association Class III or IV heart failure (see Study Procedures Manual [SPM]).
- Evidence of current, uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Fridericia corrected QT interval (QTcF) >450 milliseconds (msec) (men) or >475 msec (women) on a 12-lead ECG during the Screening period.
- Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that, in the opinion of the treating physician, are considered to be clinically significant.
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance to study drugs, including difficulty swallowing tablets, diarrhea > Grade I despite supportive therapy.
- Use or consumption of any of the following medications, supplements, or foods/beverages that are inhibitors or inducers of P-gp or strong reversible inhibitors or inducers of CYP3A within the indicated timeframes below. Note that use or consumption of these substances is not permitted during the study.
- Inhibitors of P-gp and/or strong reversible inhibitors of CYP3A within 5 times the inhibitor half-life (if a reasonable half-life estimate is known), or within 7 days (if a reasonable half-life estimate is unknown), before the first dose of study drug. In general, the use of these agents is not permitted during the study except in cases where an AE must be managed. See SPM for a nonexhaustive list of strong CYP3A reversible inhibitors and/ or Pgp inhibitors based on the FDA Draft DDI Guidance.
- Strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days, or within 5 times the inhibitor or inducer half-life (whichever is longer), before the first dose of study drug. However, if a patient has a strong indication for fungal prophylaxis, then the moderate CYP3A inhibitors fluconazole or isovuconazole (mold-active) is recommended for prophylaxis, and the TAK-659 dose should be reduced to 60mg, along with increased scrutiny for toxicity. Similarly, if the patient develops a fungal infection during a productive intervention with TAK-659/Ixazomib combination, isovuconazole (mold-active) should be used, along with increased scrutiny for toxicity. In general, the use of these agents is not recommended during the study except in cases where such an AE must be managed, and the intermittent schedule of TAK-659/Ixazomib combination will not prevent profound neutropenia. See SPM for a non-exhaustive list of strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers based on the FDA Draft DDI Guidance.
- Grapefruit-containing food or beverages within 5 days before the first dose of study drug.
- Lack of suitable venous access for the study-required blood sampling.
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient has Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Phase I/II Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition of the Proteasome Inhibitor Ixazomib: Big Ten Cancer Research Consortium BTCRC-HEM17-092
This is a Phase I/II study augmenting TAK-659 action in relapsed/refractory AML by addition of the proteasome inhibitor Ixazomib. Phase I of the study will determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of TAK-659 and Ixazomib. During the phase I, dose escalation will be conducted according to a standard 3+3 dose escalation schema, and up to 18 response-evaluable patients will be enrolled. Phase II of the study will evaluate the efficacy of the combination by measuring the overall response rate (ORR).
- Conditions
- AML, AML, Adult
- Being tested
- TAK-659, Ixazomib
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-659Drug
TAK-659
IxazomibDrug
Ixazomib
| Study group | Role | What they receive |
|---|---|---|
| Phase I:TAK-659 + Ixazomib | Experimental | Phase I: TAK-659 (Days 1-15) + Ixazomib dose escalation (Days 1, 8, 15) Receives: Drug: TAK-659; Drug: Ixazomib |
| Phase II:TAK-659 + Ixazomib | Experimental | Phase II: TAK-659 at MTD (Days 1-15) + Ixazomib at MTD (Days 1, 8, 15) Receives: Drug: TAK-659; Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose(s) (RP2D)
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose(s) (RP2D) of the combination of TAK-659 and Ixazomib in patients with relapsed or refractory AML.
Measured: At the end of Cycle 2(each cycle is 28 days)
Overall Response Rate for Phase II Subjects.
To evaluate preliminary efficacy of TAK-659 plus Ixazomib in relapsed or refractory AML as measured by overall response rate (ORR).
Overall response rate (ORR) defined as CR, CRp, CRi, and PR per Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia.
Measured: Overall Response rate is assessed at the end of 4 cycles ; 4 months.
Secondary outcomes (5)
Duration of Response (DOR) for Phase II Subjects
DOR defined as the time from the date of first documentation of a response to the date of first documented progressive disease
Measured: Up to two years after the date of the first documented response.
Time to Progression (TTP) for Phase II Subjects
TTP defined as the time from first dose of study drug until tumor progression as defined by the Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia
Measured: time from first dose of study drug until tumor progression up to two years after the date of the first documented response.
Overall Survival (OS) for Phase II Subjects
OS defined as the time from the date of study entry to death
Measured: time from the date of study entry up to two years.
Frequency of Grade 3 and Higher Adverse Events for Phase II Subjects
Summarize Grade 3 and higher adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: From date of first dose until 30 days after the last treatment up to 1 year.
Mortality Rate at 3 and 6 Months for Phase II Subjects
Number of deaths at 3 and 6 moths are assessed in Phase II subjects.
Measured: From start of treatment up to 2 years or until death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start20 Sep 2019
- Primary completion22 Sep 2021
- Study completion23 Feb 2022
Why it stopped: Funder requested termination due to halting internal development of TAK-659
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- H Scott Boswell
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor-investigator, H Scott Boswell, Big Ten Cancer Research Consortium
- Investigators
- H Scott Boswell, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079738
- Sponsor's protocol ID
- BTCRC-HEM17-092
- Status last verified
- Aug 2023
- First submitted
- 3 Sep 2019
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pasupuleti SK, Rangaraju S, Layer J, Padam KSR, Cripe LD, Sayar H, Sargent KJ, Weisenbach J, Konig H, Salman H, Ramdas B, Palam LR, Mayo LD, Khan I, Dave UP, Boswell HS, Kapur R. FLT3-SYK inhibitor and Ixazomib combination impact HOXA and oxidative stress control by beta-catenin, SQSTM1 and NRF2 in AML. NPJ Precis Oncol. 2026 Feb 26;10(1):168. doi: 10.1038/s41698-026-01332-1.
PubMed 41748936
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition of the Proteasome Inhibitor Ixazomib: Big Ten Cancer Research Consortium BTCRC-HEM17-092
- ClinicalTrials.gov ID
- NCT04079738
- Acronym / sponsor ID
- BTCRC-HEM17-092
- Conditions
- AML, AML, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funder requested termination due to halting internal development of TAK-659
- Enrolment
- 8 participants (actual)
- Lead sponsor
- H Scott BoswellUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 13 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 is a Phase I/II study augmenting TAK-659 action in relapsed/refractory AML by addition of the proteasome inhibitor Ixazomib. Phase I of the study will determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of TAK-659 and Ixazomib. During the phase I, dose escalation will be conducted according to a standard 3+3 dose escalation schema, and up to 18 response-evaluable patients will be enrolled. Phase II of the study will evaluate the efficacy of the combination by measuring the overall response rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I:TAK-659 + Ixazomib | Experimental | Drug: TAK-659, Drug: IxazomibPhase I: TAK-659 (Days 1-15) + Ixazomib dose escalation (Days 1, 8, 15) |
| Phase II:TAK-659 + Ixazomib | Experimental | Drug: TAK-659, Drug: IxazomibPhase II: TAK-659 at MTD (Days 1-15) + Ixazomib at MTD (Days 1, 8, 15) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Male or female patients 18 years or older at the time of consent.
- Patients must have a diagnosis of primary or secondary AML with relapsed or refractory disease (WHO update 2016, [34]) other than acute promyelocytic leukemia, or complex karyotype or monosomy 7 (or containing monosomy 7) for whom no standard therapies are anticipated to result in a durable remission according to the clinical judgment of the treating physician, or in a patient who refuses standard therapies.
- Must have submitted for Next Generation Sequencing (NGS) testing by: 1) (preferred) having submitted a tumor sample for commercial myeloid NGS from Foundation One, Mayo, Tempus, Quest, ARUP or an institutional CLIA-certified laboratory and/or 2) obtaining a bone marrow aspirate during screening for submission to Foundation One, Mayo, Tempus, Quest, ARUP or an institutional CLIA-certified laboratory and ordered as standard of care. If bone marrow aspiration has failed, a peripheral blood sample with circulating blasts may be substituted. Screening reports on tumor cytogenetics and/or mutation assays (eg, FLT-3, and NGS) performed as part of the standard of care will be recorded in the study database or obtained at the time of screening if not previously available.
- Patient's disease must be characterized for the presence/absence of Flt3ITD/TKD mutation from an FDA-approved vendor (ex. LabPMM).
Key exclusion criteria (27 listed)
- Clinically active central nervous system leukemia.
- Female patients who are lactating and breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
- Female patients who have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
- Any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially jeopardize the safety of the patient or interfere with the objectives of the study.
- Prior treatment with investigational agents ≤ 21 days or ≤ 5 half-lives (whichever is shorter) before the first dose of study treatment. A minimum of 10 days should elapse from prior investigational therapy to initiating protocol 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 |
|---|---|---|
| TAK-659TAK-659 | Drug | Phase I:TAK-659 + Ixazomib, Phase II:TAK-659 + Ixazomib |
| IxazomibIxazomib | Drug | Phase I:TAK-659 + Ixazomib, Phase II:TAK-659 + Ixazomib |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose(s) (RP2D)
Time frame: At the end of Cycle 2(each cycle is 28 days)
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose(s) (RP2D) of the combination of TAK-659 and Ixazomib in patients with relapsed or refractory AML.
Overall Response Rate for Phase II Subjects.
Time frame: Overall Response rate is assessed at the end of 4 cycles ; 4 months.
To evaluate preliminary efficacy of TAK-659 plus Ixazomib in relapsed or refractory AML as measured by overall response rate (ORR). Overall response rate (ORR) defined as CR, CRp, CRi, and PR per Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia.
5 secondary outcomes
Duration of Response (DOR) for Phase II Subjects
Time frame: Up to two years after the date of the first documented response.
Time to Progression (TTP) for Phase II Subjects
Time frame: time from first dose of study drug until tumor progression up to two years after the date of the first documented response.
Overall Survival (OS) for Phase II Subjects
Time frame: time from the date of study entry up to two years.
Frequency of Grade 3 and Higher Adverse Events for Phase II Subjects
Time frame: From date of first dose until 30 days after the last treatment up to 1 year.
Mortality Rate at 3 and 6 Months for Phase II Subjects
Time frame: From start of treatment up to 2 years or until death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41748936Pasupuleti SK, Rangaraju S, Layer J, Padam KSR, Cripe LD, Sayar H, Sargent KJ, Weisenbach J, Konig H, Salman H, Ramdas B, Palam LR, Mayo LD, Khan I, Dave UP, Boswell HS, Kapur R. FLT3-SYK inhibitor and Ixazomib combination impact HOXA and oxidative stress control by beta-catenin, SQSTM1 and NRF2 in AML. NPJ Precis Oncol. 2026 Feb 26;10(1):168. doi: 10.1038/s41698-026-01332-1.
- 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.
H Scott Boswell, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAK-659 and Ixazomib in people with AML and AML, Adult, run by H Scott Boswell 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 24 inclusion and 27 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 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 combined 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.
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 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 (MTD) and Recommended Phase 2 Dose(s) (RP2D) (time frame: At the end of Cycle 2(each cycle is 28 days)). 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?
On the ClinicalTrials.gov record for NCT04079738, which also lists 1 linked publication.
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 Sep 2023.