NeoplasmsPhase 1NCT03604445
This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)
A Phase 1 study testing BI 905677 in people with Neoplasms, run by Boehringer Ingelheim at 5 sites in 4 countries.
Trial summary
This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BI 905677
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 8 Aug 2018to 27 Jul 2022
- 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
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1).
- Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted treatment options known to prolong survival for their disease.
- Patient willing to undergo mandatory skin biopsy at the timepoints specified in the protocol.
- Eastern Cooperative Oncology Group score of 0 or 1.
- Adequate organ function defined as all of the following:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; haemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L without the use of hematopoietic growth factors within 4 weeks of start of study medication.
Show all 15Show fewer
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
- Creatinine ≤ 1.5 x ULN. If creatinine is > 1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥ 50 ml/min (measured or calculated by CKDEPI formula or Japanese version of CKD-EPI formula for Japanese patients).
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN
- Alkaline Phosphatase < 5 x ULN
- Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia and stable sensory neuropathy which must be ≤ CTCAE Grade 2).
- At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.
- Male or female patients. Women of childbearing potential (WOCBP) must only be included after a confirmed menstrual period within the past 4 weeks and a negative pregnancy test at screening. WOCBP with irregular menstruation may be included after two negative pregnancy tests during screening between 2 and 4 weeks apart. WOCBP and men who are able to father a child must be ready and able to use highly effective methods of birth control, per ICH M3 (R2), that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of BI 905677. A list of contraception methods meeting these criteria is provided in the patient information.
Who cannot join
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening.
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except;
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local treatment
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- Osteoporosis ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Chronic corticosteroid use
- Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Previous treatment in this trial.
- Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
- Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the safety and efficacy of the test drug.
- Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 6 months after the last dose of study treatment.
- Active alcohol or drug abuse in the opinion of the investigator.
- Patient unwilling or unable to comply with the protocol.
- Presence or history of uncontrolled or symptomatic brain or subdural metastases, unless considered stable by the investigator and local therapy was completed. Inclusion of patients with newly identified brain metastasis/es at screening will be allowed if patients are asymptomatic.
- Known history of human immunodeficiency virus (HIV) infection or an active hepatitis B or C infection which in the opinion of the investigator may interfere with participation in the trial.
- History of severe hypersensitivity reactions to monoclonal antibodies.
- History of allergy to kanamycin or similar class drugs (including streptomycin, gentamicin, amikacin, tobramycin and neomycin).
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
University of Southern California
Los Angeles, California, 90033
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours
This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.
One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.
- Conditions
- Neoplasms
- Being tested
- BI 905677
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 905677Drug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| BI 905677 0.05 mg/kg | Experimental | 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 0.1 mg/kg | Experimental | 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 0.2 mg/kg | Experimental | 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 0.4 mg/kg | Experimental | 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 0.8 mg/kg | Experimental | 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 1.6 mg/kg | Experimental | 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 2.4 mg/kg | Experimental | 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 2.8 mg/kg | Experimental | 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
| BI 905677 3.6 mg/kg | Experimental | 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. Receives: Drug: BI 905677 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of >5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.
Measured: In the first treatment cycle, up to 3 weeks
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.
Measured: From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.
Secondary outcomes (2)
Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)
The Maximum measured concentration of BI 905677 in serum after first infusion is reported.
Measured: 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)
The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported.
Measured: 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start8 Aug 2018
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Why it stopped: Sponsor decision
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604445
- Sponsor's protocol ID
- 1401-0001
- Other IDs
- 2017-002945-31, 2017
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2018
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Publications
Lenz HJ, Argiles G, de Jonge MJA, Yaeger R, Doi T, El-Khoueiry A, Eskens F, Kuboki Y, Bertulis J, Nazabadioko S, Pronk L, Tabernero J. A phase I dose-escalation study of LRP5/6 antagonist BI 905677 in patients with advanced solid tumors. ESMO Open. 2024 Nov;9(11):103729. doi: 10.1016/j.esmoop.2024.103729.
PubMed 39617530
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT03604445
- Acronym / sponsor ID
- 1401-0001
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.
One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| BI 905677 0.05 mg/kg | Experimental | Drug: BI 9056770.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 0.1 mg/kg | Experimental | Drug: BI 9056770.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 0.2 mg/kg | Experimental | Drug: BI 9056770.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 0.4 mg/kg | Experimental | Drug: BI 9056770.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 0.8 mg/kg | Experimental | Drug: BI 9056770.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 1.6 mg/kg | Experimental | Drug: BI 9056771.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 2.4 mg/kg | Experimental | Drug: BI 9056772.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 2.8 mg/kg | Experimental | Drug: BI 9056772.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
| BI 905677 3.6 mg/kg | Experimental | Drug: BI 9056773.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1).
- Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted treatment options known to prolong survival for their disease.
- Patient willing to undergo mandatory skin biopsy at the timepoints specified in the protocol.
- Eastern Cooperative Oncology Group score of 0 or 1.
- Adequate organ function defined as all of the following:
Key exclusion criteria (20 listed)
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening.
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except;
- Osteoporosis ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Chronic corticosteroid use
- Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
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 |
|---|---|---|
| BI 905677Solution for infusion | Drug | BI 905677 0.05 mg/kg, BI 905677 0.1 mg/kg, BI 905677 0.2 mg/kg, BI 905677 0.4 mg/kg, BI 905677 0.8 mg/kg, BI 905677 1.6 mg/kg, BI 905677 2.4 mg/kg, BI 905677 2.8 mg/kg, BI 905677 3.6 mg/kg |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: In the first treatment cycle, up to 3 weeks
The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of >5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
Time frame: From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.
The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.
2 secondary outcomes
Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)
Time frame: 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)
Time frame: 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39617530Lenz HJ, Argiles G, de Jonge MJA, Yaeger R, Doi T, El-Khoueiry A, Eskens F, Kuboki Y, Bertulis J, Nazabadioko S, Pronk L, Tabernero J. A phase I dose-escalation study of LRP5/6 antagonist BI 905677 in patients with advanced solid tumors. ESMO Open. 2024 Nov;9(11):103729. doi: 10.1016/j.esmoop.2024.103729.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 905677 in people with Neoplasms, run by Boehringer Ingelheim at 5 sites in 4 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 15 inclusion and 20 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 4 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 5 sites in United States, Japan, Netherlands, 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 4 Mar 2024). 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?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: In the first treatment cycle, up to 3 weeks). 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 NCT03604445, 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 4 Mar 2024.