Extranodal NK/T-cell Lymphoma, Nasal TypePhase 1/2NCT04509466
Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
A Phase 1/2 study testing Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase, Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase and Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a multicentre, open-label, single-arm, phase I/II clinical study to evaluate the safety, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with pegaspargase in patients with extranodal natural killer/T-cell lymphoma, nasal type (NKTCL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- What is being tested?
- Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase, Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase and Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to 30 Jan 2022
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, ≤75 years, no gender limitation;
- Histologically confirmed diagnosis of treatment-naïve, relapsed or refractory extranodal NK/T-cell lymphoma nasal type (NKTCL);
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- At least one measurable lesion as per Lugano 2014 criteria;
- Adequate bone marrow, liver, renal and coagulation function
Who cannot join
- Known central nervous system involvement caused by lymphoma;
- Known infiltration of the bone marrow according to criteria for leukemia (≥20% myeloblast in the blood or bone marrow);
- Known hemophagocytic syndrome;
- History of allergy and contraindications to mitoxantrone hydrochloride and/or asparaginase/ pegaspargase;
- Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug (2 weeks for the local radiation therapy for pain relief);
- Life expectancy < 3 months
Show all 18Show fewer
- Impaired cardiac function or serious cardiac disease;
- Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;
- Acute symptomatic or chronic pancreatitis within 4 weeks prior to screening;
- History of, or known additional tumor (exception: non-melanoma skin cancer (in situ) and cervical cancer (in situ) which have been cured and have not recurred within 5 years);
- History of solid organ transplantation, autologous hematopoietic stem cell transplantation within 6 months prior to screening, or allogeneic hematopoietic stem cell transplantation before screening;
- Major surgery within 4 weeks prior to screening. Or have a surgical schedule during the study period;
- A serious infection within 4 weeks prior to screening and not suitable for the study according to the judgment of the investigator;
- Uncontrolled diabetes at screening;
- Known alcohol or drug abuse;
- Known psychiatric disorders or cognitive disorder;
- 17. Pregnant or breastfeeding women, or patients who are expecting to conceive or father in 12 months (starting with the screening visit)；
- Not suitable for this study as determined by the investigator due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
About this study
Official title: A Multicentre, Open-label, Single-arm, Phase I/II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
This is a multicentre, open-label, single-arm, phase I/II clinical study to evaluate the safety, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with pegaspargase in patients with extranodal natural killer/T-cell lymphoma, nasal type (NKTCL).
Read the detailed description
This is a multicentre, open-label, single-arm, phase I/II clinical study with a dose-escalation stage (part 1) and a dose-expansion stage (part 2). In part 1, patients with treatment-naïve, relapsed/refractory extranodal natural killer/T-cell lymphoma (nasal type) will be assigned to receive sequentially higher doses of liposomal mitoxantrone hydrochloride plus a standard dose of pegaspargase every 21 days (a cycle). The dose escalation initially will follow an accelerated titration design for the first two dosing groups, then follow a classic 3+3 design. All dose-escalation decisions will be based on the safety data generated from the currently highest dose group. The maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of liposomal mitoxantrone hydrochloride will be determined in part 1. In part 2, additional patients will be recruited into two groups,the treatment-naïve group and the relapsed or refractory group, to receive liposomal mitoxantrone hydrochloride at the RP2D combined with a standard dose of pegaspargase. All patients will receive the treatment until disease progression, or observation of unacceptable grade 3 drug-related adverse events (a maximum of 6 cycles).
- Being tested
- Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase, Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase, Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1: Liposomal mitoxantrone hydrochloride and PegaspargaseDrug
Also called Part 1
Drug: Liposomal mitoxantrone hydrochloride (12mg/m2, 16mg/m2, 20mg/m2, 24mg/m2) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle.
Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and PegaspargaseDrug
Also called Part 2 (treatment-naïve patients)
Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle.
Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and PegaspargaseDrug
Also called Part 2 (relapsed or refractory patients)
Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation (part 1) | Experimental | dose escalation (part 1):Patients with treatment-naïve, relapsed or refractory extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. The starting dose of liposomal mitoxantrone hydrochloride is 12mg/m2.dose expansion, treatment-naïve patients (part 2):Patients with treatment-naïve extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride at RP2D plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles.
dose expansion, relapsed or refractory patients (part 2):Patients with relapsed or refractor extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride at RP2D plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. Receives: Drug: Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase; Drug: Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase; Drug: Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1：dose limiting toxicities (DLTs)
The incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Measured: Cycle 1 (a cycle = 21 days)
Part 2 (treatment-naïve patients):The percentage of patients who achieve complete response (CR)
CR rates at the end of chemotherapy
Measured: up to 18 weeks
Part 2 (relapsed or refractory patients):The percentage of patients who achieve complete response (CR)
CR rates at the end of treatment(including chemotherapy and radiation)
Measured: up to 26 weeks
Part 2 (relapsed or refractory patients):The percentage of patients who achieve partial response (PR)
PR rates at the end of treatment(including chemotherapy and radiation)
Measured: up to 26 weeks
Secondary outcomes (10)
Part 1 the preliminary antitumor efficacy: complete response rate (CR)
the percentage of patients who achieve complete response (CR)（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Part 1 the preliminary antitumor efficacy：overall response rate (ORR)
the percentage of patients who achieve complete response (CR）and partial response (PR)（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Part 1 the preliminary antitumor efficacy:disease control rate (DCR)
the percentage of patients who achieve complete response (CR）、partial response (PR) and stable disease（SD）（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Part 1: The pharmacokinetic parameters Cmax
maximum concentration(Cmax)
Measured: At the end of Cycle 1 and Cycle 3 (each cycle is 21 days)
Part 1: The pharmacokinetic parameters AUC0-t
area under the curve from zero to the time point（AUC0-t）
Measured: At the end of Cycle 1 and Cycle 3 (each cycle is 21 days)
Part 2 (treatment-naïve patients):The preliminary antitumor efficacy complete response rate (CR)
the percentage of patients who achieve complete response (CR)（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Part 2 (treatment-naïve patients):The preliminary antitumor efficacy overall response rate (ORR)
the percentage of patients who achieve complete response (CR）and partial response (PR)（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Part 2 (treatment-naïve patients):The preliminary antitumor efficacy disease control rate (DCR)
the percentage of patients who achieve complete response (CR）、partial response (PR) and stable disease（SD）（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Part 2 (treatment-naïve patients):The preliminary safety index
The incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Measured: through study completion, an average of 1 year
Part 2 (relapsed or refractory patients): The preliminary antitumor efficacy
disease control rate (DCR)：the percentage of patients who achieve complete response (CR）、partial response (PR) and stable disease（SD）（including at the end of chemotherapy and at the end of treatment）
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start15 Sep 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Why it stopped: The sponsor has adjusted its R\&D strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ping Liu, Principal investigator, 39 Lianhuachi East Road, Haidian Dist., Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509466
- Sponsor's protocol ID
- HE071-CSP-012
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Single-arm, Phase I/II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
- ClinicalTrials.gov ID
- NCT04509466
- Acronym / sponsor ID
- HE071-CSP-012
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has adjusted its R\&D strategy.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 12 Aug 2020 (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.
This is a multicentre, open-label, single-arm, phase I/II clinical study to evaluate the safety, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with pegaspargase in patients with extranodal natural killer/T-cell lymphoma, nasal type (NKTCL).
Detailed description
This is a multicentre, open-label, single-arm, phase I/II clinical study with a dose-escalation stage (part 1) and a dose-expansion stage (part 2). In part 1, patients with treatment-naïve, relapsed/refractory extranodal natural killer/T-cell lymphoma (nasal type) will be assigned to receive sequentially higher doses of liposomal mitoxantrone hydrochloride plus a standard dose of pegaspargase every 21 days (a cycle). The dose escalation initially will follow an accelerated titration design for the first two dosing groups, then follow a classic 3+3 design. All dose-escalation decisions will be based on the safety data generated from the currently highest dose group. The maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of liposomal mitoxantrone hydrochloride will be determined in part 1. In part 2, additional patients will be recruited into two groups,the treatment-naïve group and the relapsed or refractory group, to receive liposomal mitoxantrone hydrochloride at the RP2D combined with a standard dose of pegaspargase. All patients will receive the treatment until disease progression, or observation of unacceptable grade 3 drug-related adverse events (a maximum of 6 cycles).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation (part 1) | Experimental | Drug: Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase, Drug: Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase, Drug: Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargasedose escalation (part 1):Patients with treatment-naïve, relapsed or refractory extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. The starting dose of liposomal mitoxantrone hydrochloride is 12mg/m2.dose expansion, treatment-naïve patients (part 2):Patients with treatment-naïve extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride at RP2D plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. dose expansion, relapsed or refractory patients (part 2):Patients with relapsed or refractor extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride at RP2D plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, ≤75 years, no gender limitation;
- Histologically confirmed diagnosis of treatment-naïve, relapsed or refractory extranodal NK/T-cell lymphoma nasal type (NKTCL);
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- At least one measurable lesion as per Lugano 2014 criteria;
Key exclusion criteria (18 listed)
- Known central nervous system involvement caused by lymphoma;
- Known infiltration of the bone marrow according to criteria for leukemia (≥20% myeloblast in the blood or bone marrow);
- Known hemophagocytic syndrome;
- History of allergy and contraindications to mitoxantrone hydrochloride and/or asparaginase/ pegaspargase;
- Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug (2 weeks for the local radiation therapy for pain relief);
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 |
|---|---|---|
| Part 1: Liposomal mitoxantrone hydrochloride and PegaspargaseAlso: Part 1Drug: Liposomal mitoxantrone hydrochloride (12mg/m2, 16mg/m2, 20mg/m2, 24mg/m2) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle. Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle. | Drug | dose escalation (part 1) |
| Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and PegaspargaseAlso: Part 2 (treatment-naïve patients)Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle. Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle. | Drug | dose escalation (part 1) |
| Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and PegaspargaseAlso: Part 2 (relapsed or refractory patients)Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle. Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle. | Drug | dose escalation (part 1) |
Primary outcome
Part 1：dose limiting toxicities (DLTs)
Time frame: Cycle 1 (a cycle = 21 days)
The incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Part 2 (treatment-naïve patients):The percentage of patients who achieve complete response (CR)
Time frame: up to 18 weeks
CR rates at the end of chemotherapy
Part 2 (relapsed or refractory patients):The percentage of patients who achieve complete response (CR)
Time frame: up to 26 weeks
CR rates at the end of treatment(including chemotherapy and radiation)
Part 2 (relapsed or refractory patients):The percentage of patients who achieve partial response (PR)
Time frame: up to 26 weeks
PR rates at the end of treatment(including chemotherapy and radiation)
10 secondary outcomes
Part 1 the preliminary antitumor efficacy: complete response rate (CR)
Time frame: up to 26 weeks
Part 1 the preliminary antitumor efficacy：overall response rate (ORR)
Time frame: up to 26 weeks
Part 1 the preliminary antitumor efficacy:disease control rate (DCR)
Time frame: up to 26 weeks
Part 1: The pharmacokinetic parameters Cmax
Time frame: At the end of Cycle 1 and Cycle 3 (each cycle is 21 days)
Part 1: The pharmacokinetic parameters AUC0-t
Time frame: At the end of Cycle 1 and Cycle 3 (each cycle is 21 days)
Part 2 (treatment-naïve patients):The preliminary antitumor efficacy complete response rate (CR)
Time frame: up to 26 weeks
Part 2 (treatment-naïve patients):The preliminary antitumor efficacy overall response rate (ORR)
Time frame: up to 26 weeks
Part 2 (treatment-naïve patients):The preliminary antitumor efficacy disease control rate (DCR)
Time frame: up to 26 weeks
Part 2 (treatment-naïve patients):The preliminary safety index
Time frame: through study completion, an average of 1 year
Part 2 (relapsed or refractory patients): The preliminary antitumor efficacy
Time frame: up to 26 weeks
Results and safety
The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Ping Liu principal investigator
39 Lianhuachi East Road, Haidian Dist., Beijing, China
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 Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase, Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase and Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 6 inclusion and 18 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.
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?
Part 1：dose limiting toxicities (DLTs) (time frame: Cycle 1 (a cycle = 21 days)). The study lists 4 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 7 Mar 2024.