Breast CancerPhase 1THELMANCT02562378
T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
A Phase 1 study testing Trastuzumab and non-pegylated liposomal doxorubicin in people with Breast Cancer, run by MedSIR at 4 sites in 2 countries.
Trial summary
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab and non-pegylated liposomal doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2015to Dec 2018
- 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
- Signed informed consent
- Patient able and willing to comply with protocol
- Cytologically or histologically confirmed carcinoma of the breast.
- Incurable locally advanced or metastatic disease who have previously received up to two previous chemotherapy regimens in this setting. Patient must have progressed or relapsed on or after taxane and trastuzumab-based therapy.
- HER2-positive disease
- At least one measurable lesion according to RECIST version 1.1; or patients with non measurable lesions could be included with these exceptions:
Show all 19Show fewer
- o patients with only blastic bone lesions / with only pleural, peritoneal or cardiac effusion, or meningeal carcinomatosis
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Life expectancy ≥ 3 months
- Adequate bone marrow function:
- Hemoglobin ≥ 10 g/dl.
- Absolute neutrophil count ≥ 1.5 x 109/L.
- Platelets ≥ 100 x 109/L without transfusions within 21 days
- International normalized ratio (INR) < 1.5 × the upper limit of normal (ULN).
- Adequate hepatic and renal function
- Adequate cardiovascular function with LVEF ≥ 55%
- Recovery from all reported toxicities of previous anti-cancer therapies to baseline or grade ≤ 1 (CTCAE version 4.0), except for alopecia
- For women of childbearing potential and not postmenopausal, and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy, and men with partners of childbearing potential, use of forms of contraception
Who cannot join
- Previous treatment with T-DM1 or anthracyclines
- More than two chemotherapeutic regimens for locally advanced incurable disease or metastatic disease
- Prior anti-cancer treatment with chemotherapy, immunotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin-C), hormonal therapy or lapatinib within 7 days, prior trastuzumab within 21 days (7 days if weekly trastuzumab) or any other targeted therapy within the last 21 days prior to starting study treatment
- Previous radiotherapy for the treatment of unresectable, locally advanced/recurrent or mBC is not allowed if:
- The last fraction of radiotherapy has been administered within 21 days prior to first study drug administration (except for brain irradiation; at least 28 days will be required)
- More than 25% of marrow-bearing bone has been irradiated
Show all 15Show fewer
- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to the active substance or to any of the excipients of T-DM1 or non-pegylated liposomal doxorubicin
- Patients with central nervous system (CNS) involvement. However, patients with metastatic CNS tumors may participate in this trial if the patient is > 4 weeks from radiotherapy completion, is clinically stable with respect to CNS tumor at the time of study entry and is not receiving steroid therapy for brain metastases
- Severe/uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Cardiopulmonary dysfunction
- Current peripheral neuropathy of Grade ≥ 3 per the NCI CTCAE, v4.0
- History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
- Prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was cured ≥ 5 years before first dose of study drug with no subsequent evidence of recurrence
- Current known active infection with HIV, hepatitis B, and/or hepatitis C virus
- Women who are pregnant or breast-feeding
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France2 sites
MedSIR investigative site
Paris, 75020
MedSIR investigative site
Paris, 92210
Spain2 sites
MedSIR investigative site
Barcelona, 00835
MedSIR investigative site
Madrid, 08035
About this study
Official title: Phase I Multicenter Clinical Trial Evaluating the Combination of Trastuzumab Emtansine (T-DM1) and Non-pegylated Liposomal Doxorubicin in HER2-positive Metastatic Breast Cancer
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy.
In addition, pharmacokinetic data on the combination of T-DM1 and liposomal doxorubicin will be obtained.
Read the detailed description
Subjects: Age ≥ 18 years with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer that have relapsed or progressed on or after taxanes and trastuzumab-based therapy. Subjects must have histologic or cytologic confirmation of the HER2-positive metastatic breast cancer. Evidence of measurable or evaluable metastatic disease is required.
Primary objective:
- To determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy.
Secondary objectives:
- To determine the efficacy of the combination of T-DM1 and non-pegylated liposomal doxorubicin, defined by the overall response rate (ORR), clinical benefit rate (CBR), number of progressions and number and reasons for deaths.
- To assess the safety profile of the combination of T-DM1 and non-pegylated liposomal doxorubicin, defined by all toxicities reported during the study.
- To evaluate the cardiac safety of the combination of T-DM1 and non-pegylated liposomal doxorubicin measured by left ventricular ejection fraction (LVEF) as assessed by echocardiography, cardiac troponin I and B-type natriuretic peptide (BNP) levels.
- To evaluate the potential role of single nucleotide polymorphisms (SNP) in the predisposition for developing cardiotoxicity.
- To analyze the pharmacokinetics (PK) profile of T-DM1 and its metabolites and non-pegylated liposomal doxorubicin.
Type of study: This is a prospective dose-finding, multicenter and open-label phase I clinical trial.
Treatment: Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and three cohorts of patients with three different dose levels of conventional non-pegylated liposomal doxorubicin (45 mg/m2, 50 mg/m2 and 60 mg/m2) IV on Day 1 in cycles of 21 days each are planned.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab and non-pegylated liposomal doxorubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab and non-pegylated liposomal doxorubicinDrug
Also called T-DM1 and non-pegylated liposomal doxorubicin
3 Cohorts (3+3 design):
Cohort 1- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
Cohort 2- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
Cohort 3- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and three cohorts of patients with three different dose levels of conventional non-pegylated liposomal doxorubicin (45 mg/m2, 50 mg/m2 and 60 mg/m2) IV Receives: Drug: Trastuzumab and non-pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological - Dose Limiting Toxicities
Treatment-related adverse events (AEs) of any grade reported in ≥10% of patients.
Measured: Baseline up to 6 weeks after patient entry (Cycle2Day21)
Non-Hematological - Dose Limiting Toxicities
Treatment-related AEs of any grade reported in ≥10% of patients.
Measured: Baseline up to 6 weeks after patient entry (Cycle2Day21)
Secondary outcomes (18)
Overall Response Rate
Patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Baseline up to 24 months after patient entry
Best Overall Response
Patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)
Measured: Baseline up to 24 months after patient entry
Clinical Benefit Rate
Clinical benefit rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks based on local investigator's assessment
Measured: Baseline up to 24 months after patient entry
Progression-free Survival
Patients with progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Baseline up to 24 months after patient entry
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Patients with grade 3/4 adverse events, Serious Adverse Events (SAEs), deaths and discontinuations
Measured: Baseline up to 24 months after patient entry
Discontinuation of the Study Drugs Due to Any Cardiotoxicity
Rate of patients who discontinued treatment due to Cardiac Function or Due to Cardiac Cause
Measured: Baseline up to 24 months after patient entry
Left Ventricular Dysfunction Class IV
New York Heart Association grading of Level II cardiotoxicities characterized by dose-independent reversible myocardial damage.
The classes used in this system, I to IV with I indicating less severity and higher numbers indicating greater severity.
Measured: Baseline up to 24 months after patient entry
Serum HER-2 Levels
Serum human epidermal growth factor receptor 2 (HER-2) Levels (ng/mL) - Cycle 1 Day 1 and Cycle 4 Day 1.
Measured: Baseline and after 4 cycles of treatment (Cycle4Day21)
Doxorubicinol - Concentration (Cmax)
Plasma concentration of Doxorubicinol using a validated liquid chromatography electrospray tandem mass spectrometry (LC-MS/MS) method
Measured: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Doxorubicinol - Area Under Curve (AUC)
Area under the plasma concentration versus time curve for the pharmacokinetic parameters for doxorubicinol by treatment dose level
Measured: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Doxorubicinol - Apparent Half-life (t1/2)
Apparent half-life for doxorubicinol by treatment dose level.
Measured: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Doxorubicinol - Tmax
Maximum concentration of drug in plasma (Tmax)
Measured: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Trastuzumab - Cmax
Pharmacokinetic parameters for trastuzumab
Measured: Baseline (Cycle1 Day1)
Trastuzumab - AUC
Pharmacokinetic parameters for trastuzumab
Measured: Baseline (Cycle1Day1)
Trastuzumab - Tmax
Pharmacokinetic parameters for trastuzumab
Measured: Baseline (Cycle1Day1)
DM-1 - Cmax
Pharmacokinetic parameters for emtansine (DM1) by treatment dose level
Measured: Baseline (Cycle1Day1)
DM-1 - AUC
Pharmacokinetic parameters for DM1 by treatment dose level
Measured: Baseline (Cycle1Day1)
DM-1 - Tmax
Pharmacokinetic parameters for DM1 by treatment dose level
Measured: Baseline (Cycle1Day1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
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 Breast CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Experior
- Responsible party
- Sponsor
- Investigators
- Javier Cortés, MD, Study director, Hospital Ramon y Cajal, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562378
- Sponsor's protocol ID
- MedOPP038
- Other IDs
- 2014-001056-28, 2014
- Acronym
- THELMA
- Status last verified
- Oct 2021
- First submitted
- 17 Sep 2015
- Last updated
- 23 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter Clinical Trial Evaluating the Combination of Trastuzumab Emtansine (T-DM1) and Non-pegylated Liposomal Doxorubicin in HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02562378
- Acronym / sponsor ID
- THELMA / MedOPP038
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Experior
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy.
In addition, pharmacokinetic data on the combination of T-DM1 and liposomal doxorubicin will be obtained.
Detailed description
Subjects: Age ≥ 18 years with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer that have relapsed or progressed on or after taxanes and trastuzumab-based therapy. Subjects must have histologic or cytologic confirmation of the HER2-positive metastatic breast cancer. Evidence of measurable or evaluable metastatic disease is required.
Primary objective:
- To determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and trastuzumab-based therapy.
Secondary objectives:
- To determine the efficacy of the combination of T-DM1 and non-pegylated liposomal doxorubicin, defined by the overall response rate (ORR), clinical benefit rate (CBR), number of progressions and number and reasons for deaths.
- To assess the safety profile of the combination of T-DM1 and non-pegylated liposomal doxorubicin, defined by all toxicities reported during the study.
- To evaluate the cardiac safety of the combination of T-DM1 and non-pegylated liposomal doxorubicin measured by left ventricular ejection fraction (LVEF) as assessed by echocardiography, cardiac troponin I and B-type natriuretic peptide (BNP) levels.
- To evaluate the potential role of single nucleotide polymorphisms (SNP) in the predisposition for developing cardiotoxicity.
- To analyze the pharmacokinetics (PK) profile of T-DM1 and its metabolites and non-pegylated liposomal doxorubicin.
Type of study: This is a prospective dose-finding, multicenter and open-label phase I clinical trial.
Treatment: Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and three cohorts of patients with three different dose levels of conventional non-pegylated liposomal doxorubicin (45 mg/m2, 50 mg/m2 and 60 mg/m2) IV on Day 1 in cycles of 21 days each are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Trastuzumab and non-pegylated liposomal doxorubicinTrastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and three cohorts of patients with three different dose levels of conventional non-pegylated liposomal doxorubicin (45 mg/m2, 50 mg/m2 and 60 mg/m2) IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent
- Patient able and willing to comply with protocol
- Cytologically or histologically confirmed carcinoma of the breast.
- Incurable locally advanced or metastatic disease who have previously received up to two previous chemotherapy regimens in this setting. Patient must have progressed or relapsed on or after taxane and trastuzumab-based therapy.
- HER2-positive disease
Key exclusion criteria (15 listed)
- Previous treatment with T-DM1 or anthracyclines
- More than two chemotherapeutic regimens for locally advanced incurable disease or metastatic disease
- Prior anti-cancer treatment with chemotherapy, immunotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin-C), hormonal therapy or lapatinib within 7 days, prior trastuzumab within 21 days (7 days if weekly trastuzumab) or any other targeted therapy within the last 21 days prior to starting study treatment
- Previous radiotherapy for the treatment of unresectable, locally advanced/recurrent or mBC is not allowed if:
- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to the active substance or to any of the excipients of T-DM1 or non-pegylated liposomal doxorubicin
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 |
|---|---|---|
| Trastuzumab and non-pegylated liposomal doxorubicinAlso: T-DM1 and non-pegylated liposomal doxorubicin3 Cohorts (3+3 design): Cohort 1- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV Cohort 2- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV Cohort 3- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV | Drug | Experimental arm |
Primary outcome
Hematological - Dose Limiting Toxicities
Time frame: Baseline up to 6 weeks after patient entry (Cycle2Day21)
Treatment-related adverse events (AEs) of any grade reported in ≥10% of patients.
Non-Hematological - Dose Limiting Toxicities
Time frame: Baseline up to 6 weeks after patient entry (Cycle2Day21)
Treatment-related AEs of any grade reported in ≥10% of patients.
18 secondary outcomes
Overall Response Rate
Time frame: Baseline up to 24 months after patient entry
Best Overall Response
Time frame: Baseline up to 24 months after patient entry
Clinical Benefit Rate
Time frame: Baseline up to 24 months after patient entry
Progression-free Survival
Time frame: Baseline up to 24 months after patient entry
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Time frame: Baseline up to 24 months after patient entry
Discontinuation of the Study Drugs Due to Any Cardiotoxicity
Time frame: Baseline up to 24 months after patient entry
Left Ventricular Dysfunction Class IV
Time frame: Baseline up to 24 months after patient entry
Serum HER-2 Levels
Time frame: Baseline and after 4 cycles of treatment (Cycle4Day21)
Doxorubicinol - Concentration (Cmax)
Time frame: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Doxorubicinol - Area Under Curve (AUC)
Time frame: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Doxorubicinol - Apparent Half-life (t1/2)
Time frame: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Doxorubicinol - Tmax
Time frame: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)
Trastuzumab - Cmax
Time frame: Baseline (Cycle1 Day1)
Trastuzumab - AUC
Time frame: Baseline (Cycle1Day1)
Trastuzumab - Tmax
Time frame: Baseline (Cycle1Day1)
DM-1 - Cmax
Time frame: Baseline (Cycle1Day1)
DM-1 - AUC
Time frame: Baseline (Cycle1Day1)
DM-1 - Tmax
Time frame: Baseline (Cycle1Day1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Javier Cortés, MD study director
Hospital Ramon y Cajal, Madrid, Spain
4 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 Trastuzumab and non-pegylated liposomal doxorubicin in people with Breast Cancer, run by MedSIR at 4 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 19 inclusion and 15 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 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Spain. 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 18 Jan 2022). 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?
Hematological - Dose Limiting Toxicities (time frame: Baseline up to 6 weeks after patient entry (Cycle2Day21)). 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 23 Feb 2022.