Castration-resistant Prostate CancerPhase 1NCT03136640
ModraDoc006/r in Metastatic Castration-resistant Prostate Cancer
A Phase 1 study testing ModraDoc006/r in people with Castration-resistant Prostate Cancer, run by Modra Pharmaceuticals at 4 sites in Netherlands.
Trial summary
This is a safety, feasibility and pharmacokinetic study to confirm that the recommended safe dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a previous phase I study is also safe and feasible in the target population of patients with CRPC. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- ModraDoc006/r
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesNetherlands
- Study dates
- 26 Apr 2017to 5 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological proven castration-resistant metastatic prostate cancer with an indication for systemic treatment with intravenous docetaxel at the discretion of the physician
- Progressive disease defined as biochemical and/or radiological progression according to the Prostate Cancer Working group 3 recommendations.
- Disease evaluable for biochemical and/or radiological response (in case disease is measurable the RECIST 1.1 criteria and the guidelines for measurement of bone lesions according to the Prostate Cancer Clinical Trials Working Group 3 will be applied, as described in "Efficacy assessment").
- Chemotherapy naïve patients. Prior treatment with abiraterone or enzalutamide as first line therapy is allowed. In case of use of enzalutamide, this should be stopped 2 weeks before the first ModraDoc006/r intake. For patients that have used enzalutamide, altered pharmacokinetic sampling should be done, as described at 'Pharmacokinetics and Circulating Tumour Cell measurements"
- Castrate levels of testosterone, defined as ≤ 50 ng/dL (or ≤ 0.50 ng/mL or 1.73 nmol/L)
- Age equal or above 18 years
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- Adequate haematological, renal and hepatic functions
- WHO performance status of 0-2
- Life expectancy above 3 months allowing adequate follow up of toxicity evaluation and antitumor activity;
- Able and willing to swallow oral medication
- Able and willing to undergo blood sampling
- Able and willing to give written informed consent
Who cannot join
- Any treatment with investigational drugs, chemotherapy or immunotherapy within 28 days prior to receiving the first dose of investigational treatment. Palliative radiotherapy is allowed before and during the study as long as this is scheduled outside the DLT-period (first 28 days) and at least 4 days after intake of study medication and no intestinal toxicity is expected from the radiotherapy.
- Patients with symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Patients with a history of leptomeningeal metastases are not eligible.
- Unreliable contraceptive methods. Men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
- Unresolved (> grade 1) toxicities of previous therapy, excluding alopecia.
- Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- Patients with a known history of hepatitis B or C;
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- Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the treating physician
- Concomitant use of MDR and CYP3A modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analogues, or St. John's wort.
- Use of Bicalutamide within 14 days prior to receiving the first dose of investigational treatment
- Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance; Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- Legal incapacity
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066CX
Radboud University Medical Center
Nijmegen, 6525 GA
Erasmus Medical Center
Rotterdam, 3015 CE
University Medical Center Utrecht
Utrecht, 3508 GA
About this study
Official title: Multicenter Safety, Feasibility and Pharmacokinetic Phase I Trial of ModraDoc006/r in Patients With Metastatic Castration-resistant Prostate Cancer
This is a safety, feasibility and pharmacokinetic study to confirm that the recommended safe dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a previous phase I study is also safe and feasible in the target population of patients with CRPC.
Read the detailed description
This is a safety, feasibility and pharmacokinetic phase II study to evaluate treatment with ModraDoc006/r (oral docetaxel with ritonavir) in chemotherapy naïve patients with castration-resistant metastatic prostate cancer for whom treatment with intravenous docetaxel is indicated. The primary objective of this study is to determine the recommended dose determined as the maximum tolerated dose (MTD) of docetaxel (as ModraDoc006 10 mg tablets) that can safely be administered in combination with ritonavir to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule without interruption and results in an adequate systemic exposure to docetaxel. On a predefined day of the first and every subsequent week, the patient will receive oral docetaxel (as ModraDoc006 10 mg tablets). This regime will be continued weekly (intake around the same time) until completion of the study, progressive disease or until adverse events, which require dose modification or discontinuation of therapy, are observed.
A dose escalation design will be used to determine the recommended dose of ModraDoc006 in combination with ritonavir that is safe and feasible and provides an adequate systemic docetaxel exposure in the target population of the projected pivotal study in patients with CRPC. Three castration-resistant metastatic prostate cancer (CRPC) patients will be assigned to the starting dose level 1A of 30-20 mg ModraDoc006 in a bi-daily weekly schedule, each intake of ModraDoc006 will be combined with 200 mg ritonavir. If no more than one DLT has occurred during the first four weeks of treatment on dose level 1A (30-20 mg ModraDoc006 and bi-daily ritonavir 200 mg) and the pharmacokinetic results are favorable, than three additional patients will be added to this dose level. If no more than 1 DLT in these first 6 patients has occurred, this will be the recommended dose and this dose level will be expanded until a total of 20 for toxicity evaluable patients have been treated on this dose level.
If 2 DLTs have occurred directly in the first 3 patients or in the first 6 patients (after the previous described addition of 3 patients), during the first four weeks of treatment on dose level 1A (30-20 mg ModraDoc006 and bi-daily 200 mg ritonavir) and the pharmacokinetic results are favorable, the dose may be de-escalated to the next lower dose-level, depending on the pharmacokinetic results and the study schedule will start again from the beginning.
If no more than one DLT has occurred in the first 6 patients during the first four weeks of treatment on dose level 1A and the pharmacokinetic results are not favorable, than the dose will be escalated depending on the pharmacokinetic results and the study schedule will start again from the beginning.
If two or more DLTs have occurred in the first 6 patients during the first four weeks of treatment on dose level 1A and the pharmacokinetic results are not favorable, the dose will be altered according to the type of DLT.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- ModraDoc006/r
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModraDoc006/rDrug
Also called oral docetaxel formulation
Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
| Study group | Role | What they receive |
|---|---|---|
| ModraDoc006/r | Experimental | Weekly ModraDoc006/r treatment as ModraDoc006 (oral docetaxel) 10mg tablets combined with ritonavir 100mg tablets Receives: Drug: ModraDoc006/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of ModraDoc006/r treatment
The maximum tolerated dose (MTD) of docetaxel (as ModraDoc006 10 mg tablets) that can safely be administered in combination with ritonavir to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule without interruption
Measured: Safety and tolerance will be evaluated using the CTCAEv4.03 grading system, dose limiting toxicities will be evaluated during the first 4 weeks of treatment
Secondary outcomes (5)
The AUC of docetaxel (area under the curve)
The AUC of docetaxel given as bi-daily ModraDoc006 10 mg tablets in combination with ritonavir
Measured: Pharmacokinetic sampling during week 1 and week 2, 0-48 hrs after administration (i.e. the first 2 treatment cycles)
The cMax (peak concentration) of docetaxel
The cMax (peak concentration) of docetaxel given as bi-daily ModraDoc006 10 mg tablets in combination with ritonavir
Measured: Pharmacokinetic sampling during week 1 and week 2, 0-48 hrs after administration (i.e. the first 2 treatment cycles)
The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir
The number of CTCAE v.4.03 grade 3-4 toxicities during treatment with ModraDoc006/r
Measured: Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAEv4.03 grading system]
The preliminary anti-tumor activity of the oral docetaxel formulation
PSA response, radiological response of visceral and nodal lesions according to RECIST 1.1, progression of bone lesions according to Prostate Cancer Working Group 3 criteria
Measured: PSA and radiological evaluation every 6 weeks, up to 30 weeks
The dose limiting toxicities (DLT) of ModraDoc006/r treatment
Determine dose limiting toxicities (DLT) and recommended dose (RD) of ModraDoc006/r that can safely be administered to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule
Measured: First 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start26 Apr 2017
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Castration-resistant Prostate 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
- Single group
- Model description
- Three patients will start at the starting dose level. If none of these patients experiences a DLT, another three patients will be added at the same dose level. The dose will be escalated or de-escalated based on safety and pharmacokinetic parameters. The recommended dose level, defined as the maximum tolerated dose (MTD) of docetaxel (as ModraDoc006 10 mg tablets) that can safely be administered in combination with ritonavir to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule without interruption and results in an adequate systemic exposure to docetaxel, will be expanded to at least 20 for toxicity evaluable patients.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modra Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Andre Bergman, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136640
- Sponsor's protocol ID
- M17DOC
- Status last verified
- Dec 2020
- First submitted
- 25 Apr 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vermunt MAC, van der Heijden LT, Hendrikx JJMA, Schinkel AH, de Weger VA, van der Putten E, van Triest B, Bergman AM, Beijnen JH. Pharmacokinetics of docetaxel and ritonavir after oral administration of ModraDoc006/r in patients with prostate cancer versus patients with other advanced solid tumours. Cancer Chemother Pharmacol. 2021 Jun;87(6):855-869. doi: 10.1007/s00280-021-04259-5. Epub 2021 Mar 20.
PubMed 33744986
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Safety, Feasibility and Pharmacokinetic Phase I Trial of ModraDoc006/r in Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03136640
- Acronym / sponsor ID
- M17DOC
- Conditions
- Castration-resistant Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Modra PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- The Netherlands Cancer Institute
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 2 May 2017 (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 safety, feasibility and pharmacokinetic study to confirm that the recommended safe dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a previous phase I study is also safe and feasible in the target population of patients with CRPC.
Detailed description
This is a safety, feasibility and pharmacokinetic phase II study to evaluate treatment with ModraDoc006/r (oral docetaxel with ritonavir) in chemotherapy naïve patients with castration-resistant metastatic prostate cancer for whom treatment with intravenous docetaxel is indicated. The primary objective of this study is to determine the recommended dose determined as the maximum tolerated dose (MTD) of docetaxel (as ModraDoc006 10 mg tablets) that can safely be administered in combination with ritonavir to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule without interruption and results in an adequate systemic exposure to docetaxel. On a predefined day of the first and every subsequent week, the patient will receive oral docetaxel (as ModraDoc006 10 mg tablets). This regime will be continued weekly (intake around the same time) until completion of the study, progressive disease or until adverse events, which require dose modification or discontinuation of therapy, are observed.
A dose escalation design will be used to determine the recommended dose of ModraDoc006 in combination with ritonavir that is safe and feasible and provides an adequate systemic docetaxel exposure in the target population of the projected pivotal study in patients with CRPC. Three castration-resistant metastatic prostate cancer (CRPC) patients will be assigned to the starting dose level 1A of 30-20 mg ModraDoc006 in a bi-daily weekly schedule, each intake of ModraDoc006 will be combined with 200 mg ritonavir. If no more than one DLT has occurred during the first four weeks of treatment on dose level 1A (30-20 mg ModraDoc006 and bi-daily ritonavir 200 mg) and the pharmacokinetic results are favorable, than three additional patients will be added to this dose level. If no more than 1 DLT in these first 6 patients has occurred, this will be the recommended dose and this dose level will be expanded until a total of 20 for toxicity evaluable patients have been treated on this dose level.
If 2 DLTs have occurred directly in the first 3 patients or in the first 6 patients (after the previous described addition of 3 patients), during the first four weeks of treatment on dose level 1A (30-20 mg ModraDoc006 and bi-daily 200 mg ritonavir) and the pharmacokinetic results are favorable, the dose may be de-escalated to the next lower dose-level, depending on the pharmacokinetic results and the study schedule will start again from the beginning.
If no more than one DLT has occurred in the first 6 patients during the first four weeks of treatment on dose level 1A and the pharmacokinetic results are not favorable, than the dose will be escalated depending on the pharmacokinetic results and the study schedule will start again from the beginning.
If two or more DLTs have occurred in the first 6 patients during the first four weeks of treatment on dose level 1A and the pharmacokinetic results are not favorable, the dose will be altered according to the type of DLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three patients will start at the starting dose level. If none of these patients experiences a DLT, another three patients will be added at the same dose level. The dose will be escalated or de-escalated based on safety and pharmacokinetic parameters. The recommended dose level, defined as the maximum tolerated dose (MTD) of docetaxel (as ModraDoc006 10 mg tablets) that can safely be administered in combination with ritonavir to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule without interruption and results in an adequate systemic exposure to docetaxel, will be expanded to at least 20 for toxicity evaluable patients.
| Arm | Type | Receives |
|---|---|---|
| ModraDoc006/r | Experimental | Drug: ModraDoc006/rWeekly ModraDoc006/r treatment as ModraDoc006 (oral docetaxel) 10mg tablets combined with ritonavir 100mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological or cytological proven castration-resistant metastatic prostate cancer with an indication for systemic treatment with intravenous docetaxel at the discretion of the physician
- Progressive disease defined as biochemical and/or radiological progression according to the Prostate Cancer Working group 3 recommendations.
- Disease evaluable for biochemical and/or radiological response (in case disease is measurable the RECIST 1.1 criteria and the guidelines for measurement of bone lesions according to the Prostate Cancer Clinical Trials Working Group 3 will be applied, as described in "Efficacy assessment").
- Chemotherapy naïve patients. Prior treatment with abiraterone or enzalutamide as first line therapy is allowed. In case of use of enzalutamide, this should be stopped 2 weeks before the first ModraDoc006/r intake. For patients that have used enzalutamide, altered pharmacokinetic sampling should be done, as described at 'Pharmacokinetics and Circulating Tumour Cell measurements"
- Castrate levels of testosterone, defined as ≤ 50 ng/dL (or ≤ 0.50 ng/mL or 1.73 nmol/L)
Key exclusion criteria (11 listed)
- Any treatment with investigational drugs, chemotherapy or immunotherapy within 28 days prior to receiving the first dose of investigational treatment. Palliative radiotherapy is allowed before and during the study as long as this is scheduled outside the DLT-period (first 28 days) and at least 4 days after intake of study medication and no intestinal toxicity is expected from the radiotherapy.
- Patients with symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Patients with a history of leptomeningeal metastases are not eligible.
- Unreliable contraceptive methods. Men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
- Unresolved (> grade 1) toxicities of previous therapy, excluding alopecia.
- Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
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 |
|---|---|---|
| ModraDoc006/rAlso: oral docetaxel formulationTreatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets | Drug | ModraDoc006/r |
Primary outcome
The maximum tolerated dose (MTD) of ModraDoc006/r treatment
Time frame: Safety and tolerance will be evaluated using the CTCAEv4.03 grading system, dose limiting toxicities will be evaluated during the first 4 weeks of treatment
The maximum tolerated dose (MTD) of docetaxel (as ModraDoc006 10 mg tablets) that can safely be administered in combination with ritonavir to patients with metastatic castration-resistant prostate cancer in a bi-daily weekly schedule without interruption
5 secondary outcomes
The AUC of docetaxel (area under the curve)
Time frame: Pharmacokinetic sampling during week 1 and week 2, 0-48 hrs after administration (i.e. the first 2 treatment cycles)
The cMax (peak concentration) of docetaxel
Time frame: Pharmacokinetic sampling during week 1 and week 2, 0-48 hrs after administration (i.e. the first 2 treatment cycles)
The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir
Time frame: Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAEv4.03 grading system]
The preliminary anti-tumor activity of the oral docetaxel formulation
Time frame: PSA and radiological evaluation every 6 weeks, up to 30 weeks
The dose limiting toxicities (DLT) of ModraDoc006/r treatment
Time frame: First 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 33744986Vermunt MAC, van der Heijden LT, Hendrikx JJMA, Schinkel AH, de Weger VA, van der Putten E, van Triest B, Bergman AM, Beijnen JH. Pharmacokinetics of docetaxel and ritonavir after oral administration of ModraDoc006/r in patients with prostate cancer versus patients with other advanced solid tumours. Cancer Chemother Pharmacol. 2021 Jun;87(6):855-869. doi: 10.1007/s00280-021-04259-5. Epub 2021 Mar 20.
- 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.
Andre Bergman, MD, PhD principal investigator
The Netherlands Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ModraDoc006/r in people with Castration-resistant Prostate Cancer, run by Modra Pharmaceuticals at 4 sites in Netherlands.
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 12 inclusion and 11 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 19 Oct 2021. 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 Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD) of ModraDoc006/r treatment (time frame: Safety and tolerance will be evaluated using the CTCAEv4.03 grading system, dose limiting toxicities will be evaluated during the first 4 weeks of treatment). 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 NCT03136640, 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 19 Oct 2021.