Advanced Solid TumorsPhase 1NCT03387917
TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors
A Phase 1 study testing TLD-1 and Caelyx in people with Advanced Solid Tumors, run by Swiss Cancer Institute at 5 sites in Switzerland.
Trial summary
TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TLD-1 and Caelyx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 12 Nov 2018to 22 Dec 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Final protocol until amendment 2: Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor who failed standard therapy or for whom no effective standard therapy is available
- From Amendment 3 on: Patients with histologically or cytologically confirmed advanced malignant tumors of the breast, ovary, uterine or sarcoma who failed standard therapy or for whom no effective standard therapy is available.
- Patients may have received up to 3 prior lines of palliative systemic chemotherapy
- Patients with brain metastases must have undergone definitive treatment (surgery and/or radiation) at least 1 month prior to starting study drug and be documented as having stable disease by imaging and are on stable doses of steroids for at least 2 weeks.
- Adequate bone marrow, renal and hepatic function
- Patients with either histologically or cytologically confirmed advanced or recurrent breast or ovarian cancer of all histologies
Show all 15Show fewer
- Histologically-confirmed ovarian, fallopian tube or primary peritoneal cancer (collectively referred to herein as 'ovarian cancer') that is either platinum-resistant (disease progression within 6 months of the last receipt of platinum-based chemotherapy) or refractory (lack of response or disease progression while receiving the most recent platinum-based therapy).
- Patients with ovarian cancer may have received up to 3 lines of prior cytotoxic chemotherapy, but maximum 1 of them in the platinumresistant/ refractory setting. Confirmed high-grade serous, endometrioid, or carcinosarcoma histotypes are permitted.
- Patients with advanced or recurrent breast cancer may have received up to 2 prior lines of palliative cytotoxic chemotherapy.
- Patients with brain metastases must have undergone definitive treatment (surgery and/or radiation) at least 1 month prior to starting study drug and be documented as having stable disease by imaging and be on stable doses of steroids for at least 2 weeks.
- Adequate bone marrow, renal and hepatic function
- Key exclusion criteria for dose escalation and comparative PK part:
- Significant cardiac disease or abnormality
- Patients who have received prior anthracyclines at a cumulative dose that exceeds 250mg/m2 for non-liposomal doxorubicin, 300mg/m2 for liposomal doxorubicin or 400mg/m2 for epirubicin and/or are refractory (during 3 months) to anthracyclines or have experienced allergic reactions or severe toxicity (grade 3 or 4) under anthracyclines
- Prior systemic chemotherapy/treatment for adjuvant/metastatic disease, radiotherapy, immunotherapy, or investigational agents within 28 days 5 half- life periods of previous therapy before registration.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
Inselspital Bern
Bern, CH-3010
Kantonsspital Graubünden
Chur, 7000
Kantonsspital St. Gallen
Sankt Gallen, 9007
Kantonsspital Winterthur
Winterthur, 8401
About this study
Official title: TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors: A Multicenter Open-label Single-arm Phase I Trial
TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Particle features including size, charge distribution, lipid composition and drug release add up to a considerably altered particle behavior compared to Caelyx®, potentially explaining the lack of hand-foot-syndrome in respective animal models. Preclinical evaluation confirmed TLD-1 to be a promising new and innovative formulation of doxorubicin with promising activity and good tolerability.
Read the detailed description
Despite impressive progress in the fields of surgical and immunological cancer therapies, most late-stage cancer treatments still heavily depend on conventional chemotherapeutics, which are often effective but also toxic, resulting in severe adverse effects limiting the dose and duration of therapy. Consequently, there remains a high unmet medical need for new innovative systemic treatments with an improved risk-benefit-profile.
Doxorubicin is a potent anthracycline used as a systemic treatment against several solid tumor including breast, ovarian and bladder cancer, small cell lung cancer and various types of sarcoma. However, Doxorubicin use is often limited due to hematological and non-hematological toxicity including cumulative cardiotoxicity with myocardial damage.
Cardiotoxicity has been substantially mitigated through the introduction of liposomal formulations such as Myocet and Caelyx/Doxil. Both products are associated with substantially lower rates of cardiac dysfunction during or post-treatment. Whereas Myocet's clinical use remains limited due to the intricate "bedside" reconstitution process, Caelyx has been associated with a high incidence of Palmar-Plantar Erythrodysesthesia (PPE) (also called hand-foot-syndrome), likely due to its long plasma half-life.
The development of TLD-1 (Talidox) aimed at combining the cardio-preserving properties of the liposomal delivery system with shorter blood circulation time in order to reduce the risk of PPE. Even though the pathophysiology of PPE is not yet fully understood, studies analyzing the correlation of dose and pharmacokinetic parameters with PLD toxic effects revealed that the severity of PPE correlated significantly with plasma half-life (t1/2).
Given its performance in preclinical trials, TLD-1 bears the potential for an improved benefit/risk profile compared to established liposomal doxorubicin formulations including Caelyx.
This first-in-human phase-I trial will evaluate the safety and will establish the maximal tolerated dose (MTD) and recommended phase II dose of TLD-1, and characterize specific dose limiting toxicities (DLT) of TLD-1. Moreover, the trial shall yield information on adverse events profile, pharmacokinetics and preliminary efficacy.
- Conditions
- Advanced Solid Tumors
- Being tested
- TLD-1, Caelyx
- Keywords
- Advanced Solid Tumors, doxorubicin, TLD-1, phase I, Talidox, Liposomal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLD-1Drug
Also called Talidox
TLD-1 is a new liposomal formulation of the anthracycline doxorubicin.
CaelyxDrug
Caelyx is a liposomal formulation of the anthracycline doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| TLD-1 | Experimental | Duration of treatment
* 1 cycle: 21 days
* 1 cycle: 28 days (only comparative PK part, in cycle 1 or 2)
* until progression or occurrence of unacceptable toxicity or withdrawal, but
* maximum 9 cycles for patients previously not treated with anthracyclines
* maximum 6 cycles for patients previously treated with anthracyclines.
* Dose: i.v., according to DL on day 1 of each cycle or tentative MTD Receives: Drug: TLD-1 |
| Caelyx (only for comparative PK part) | Experimental | Duration of treatment
* 1 cycle: 28 days
* Caelyx is given only in one cycle (cycle 1 or 2)
* Dose: i.v., 40mg/m2 Receives: Drug: Caelyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: at 3 weeks
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: volume of distribution [Vd]
Measured: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Area under curve [AUC]
Measured: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Area under curve [Cmax]
Measured: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Terminal half life [t½]
Measured: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Clearance (CL)
Measured: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Ratio of unencapsulated to encapsulated drug over time for Caelyx and TLD-1
Measured: 2 months
Secondary outcomes (7)
Adverse Events (AEs)
Measured: at 7 months
Objective tumor response (OR)
Measured: at 7 months
Time to treatment failure (TTF)
Measured: at 7 months
Population pharmacokinetics (PK) of TLD-1: clearance (CL)
Measured: at 2 months
Population pharmacokinetics (PK) of TLD-1: volume of distribution (Vd)
Measured: at 2 months
Population pharmacokinetics: Area Under the Curve [AUC]
Measured: at 2 months
Population pharmacokinetics: Maximum Plasma Concentration [Cmax]
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start12 Nov 2018
- Primary completion22 Sep 2023
- Study completion22 Dec 2023
Why it stopped: The premature termination is based on the unexpectedly low patient accrual to the clinical trial and the strategic considerations in the development of the TLD-1 after having included 13 out of 14 patients in the comparative PK part.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- The trial uses an accelerated titration design (ATD) up to the occurrence of the first DLT, followed by a modified continual reassessment method (mCRM) for dose escalation part and randomized cross-over design for the comparative PK part
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dagmar Hess, MD, Study chair, Cantonal Hospital of St. GallenAnastasios Stathis, MD, Study director, IOSI, Ospedale San GiovanniMarkus Jörger, Prof, Study director, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387917
- Sponsor's protocol ID
- SAKK 65/16
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2017
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klose M, Colombo I, Gobat K, Koster KL, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Zurrer-Hardi U, Eckhardt K, Hayoz S, Halbherr S, Sessa C, Michelet R, Mc Laughlin AM, Hess D, Stathis A, Kloft C, Joerger M. TLD-1, a Novel Liposomal Doxorubicin, in Patients with Solid Tumors: Comparative Pharmacokinetics and Final Results of a Multicenter Phase 1 Study (SAKK 65/16). Clin Pharmacokinet. 2026 Feb;65(2):217-228. doi: 10.1007/s40262-025-01588-z. Epub 2025 Nov 18.
PubMed 41252081Mc Laughlin AM, Hess D, Michelet R, Colombo I, Haefliger S, Bastian S, Rabaglio M, Schwitter M, Fischer S, Eckhardt K, Hayoz S, Kopp C, Klose M, Sessa C, Stathis A, Halbherr S, Huisinga W, Joerger M, Kloft C. Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial. Cancer Chemother Pharmacol. 2024 Sep;94(3):349-360. doi: 10.1007/s00280-024-04679-z. Epub 2024 Jun 15.
PubMed 38878207Colombo I, Koster KL, Holer L, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Eckhardt K, Hayoz S, Mc Laughlin AM, Kloft C, Klose M, Halbherr S, Baumgartner C, Sessa C, Stathis A, Hess D, Joerger M. TLD-1, a novel liposomal doxorubicin, in patients with advanced solid tumors: Dose escalation and expansion part of a multicenter open-label phase I trial (SAKK 65/16). Eur J Cancer. 2024 Apr;201:113588. doi: 10.1016/j.ejca.2024.113588. Epub 2024 Feb 2.
PubMed 38377773
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors: A Multicenter Open-label Single-arm Phase I Trial
- ClinicalTrials.gov ID
- NCT03387917
- Acronym / sponsor ID
- SAKK 65/16
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, doxorubicin, TLD-1, phase I, Talidox, Liposomal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The premature termination is based on the unexpectedly low patient accrual to the clinical trial and the strategic considerations in the development of the TLD-1 after having included 13 out of 14 patients in the comparative PK part.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 2 Jan 2018 (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.
TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Particle features including size, charge distribution, lipid composition and drug release add up to a considerably altered particle behavior compared to Caelyx®, potentially explaining the lack of hand-foot-syndrome in respective animal models. Preclinical evaluation confirmed TLD-1 to be a promising new and innovative formulation of doxorubicin with promising activity and good tolerability.
Detailed description
Despite impressive progress in the fields of surgical and immunological cancer therapies, most late-stage cancer treatments still heavily depend on conventional chemotherapeutics, which are often effective but also toxic, resulting in severe adverse effects limiting the dose and duration of therapy. Consequently, there remains a high unmet medical need for new innovative systemic treatments with an improved risk-benefit-profile.
Doxorubicin is a potent anthracycline used as a systemic treatment against several solid tumor including breast, ovarian and bladder cancer, small cell lung cancer and various types of sarcoma. However, Doxorubicin use is often limited due to hematological and non-hematological toxicity including cumulative cardiotoxicity with myocardial damage.
Cardiotoxicity has been substantially mitigated through the introduction of liposomal formulations such as Myocet and Caelyx/Doxil. Both products are associated with substantially lower rates of cardiac dysfunction during or post-treatment. Whereas Myocet's clinical use remains limited due to the intricate "bedside" reconstitution process, Caelyx has been associated with a high incidence of Palmar-Plantar Erythrodysesthesia (PPE) (also called hand-foot-syndrome), likely due to its long plasma half-life.
The development of TLD-1 (Talidox) aimed at combining the cardio-preserving properties of the liposomal delivery system with shorter blood circulation time in order to reduce the risk of PPE. Even though the pathophysiology of PPE is not yet fully understood, studies analyzing the correlation of dose and pharmacokinetic parameters with PLD toxic effects revealed that the severity of PPE correlated significantly with plasma half-life (t1/2).
Given its performance in preclinical trials, TLD-1 bears the potential for an improved benefit/risk profile compared to established liposomal doxorubicin formulations including Caelyx.
This first-in-human phase-I trial will evaluate the safety and will establish the maximal tolerated dose (MTD) and recommended phase II dose of TLD-1, and characterize specific dose limiting toxicities (DLT) of TLD-1. Moreover, the trial shall yield information on adverse events profile, pharmacokinetics and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial uses an accelerated titration design (ATD) up to the occurrence of the first DLT, followed by a modified continual reassessment method (mCRM) for dose escalation part and randomized cross-over design for the comparative PK part
| Arm | Type | Receives |
|---|---|---|
| TLD-1 | Experimental | Drug: TLD-1Duration of treatment * 1 cycle: 21 days * 1 cycle: 28 days (only comparative PK part, in cycle 1 or 2) * until progression or occurrence of unacceptable toxicity or withdrawal, but * maximum 9 cycles for patients previously not treated with anthracyclines * maximum 6 cycles for patients previously treated with anthracyclines. * Dose: i.v., according to DL on day 1 of each cycle or tentative MTD |
| Caelyx (only for comparative PK part) | Experimental | Drug: CaelyxDuration of treatment * 1 cycle: 28 days * Caelyx is given only in one cycle (cycle 1 or 2) * Dose: i.v., 40mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Final protocol until amendment 2: Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor who failed standard therapy or for whom no effective standard therapy is available
- From Amendment 3 on: Patients with histologically or cytologically confirmed advanced malignant tumors of the breast, ovary, uterine or sarcoma who failed standard therapy or for whom no effective standard therapy is available.
- Patients may have received up to 3 prior lines of palliative systemic chemotherapy
- Patients with brain metastases must have undergone definitive treatment (surgery and/or radiation) at least 1 month prior to starting study drug and be documented as having stable disease by imaging and are on stable doses of steroids for at least 2 weeks.
- Adequate bone marrow, renal and hepatic function
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TLD-1Also: TalidoxTLD-1 is a new liposomal formulation of the anthracycline doxorubicin. | Drug | TLD-1 |
| CaelyxCaelyx is a liposomal formulation of the anthracycline doxorubicin | Drug | Caelyx (only for comparative PK part) |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: at 3 weeks
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: volume of distribution [Vd]
Time frame: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Area under curve [AUC]
Time frame: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Area under curve [Cmax]
Time frame: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Terminal half life [t½]
Time frame: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Clearance (CL)
Time frame: 2 months
Descriptive pharmacokinetics (PK) of TLD-1 vs Caelyx: Ratio of unencapsulated to encapsulated drug over time for Caelyx and TLD-1
Time frame: 2 months
7 secondary outcomes
Adverse Events (AEs)
Time frame: at 7 months
Objective tumor response (OR)
Time frame: at 7 months
Time to treatment failure (TTF)
Time frame: at 7 months
Population pharmacokinetics (PK) of TLD-1: clearance (CL)
Time frame: at 2 months
Population pharmacokinetics (PK) of TLD-1: volume of distribution (Vd)
Time frame: at 2 months
Population pharmacokinetics: Area Under the Curve [AUC]
Time frame: at 2 months
Population pharmacokinetics: Maximum Plasma Concentration [Cmax]
Time frame: at 2 months
Results and safety
The study was stopped early (reason given: The premature termination is based on the unexpectedly low patient accrual to the clinical trial and the strategic considerations in the development of the TLD-1 after having included 13 out of 14 patients in the comparative PK part.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 41252081Klose M, Colombo I, Gobat K, Koster KL, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Zurrer-Hardi U, Eckhardt K, Hayoz S, Halbherr S, Sessa C, Michelet R, Mc Laughlin AM, Hess D, Stathis A, Kloft C, Joerger M. TLD-1, a Novel Liposomal Doxorubicin, in Patients with Solid Tumors: Comparative Pharmacokinetics and Final Results of a Multicenter Phase 1 Study (SAKK 65/16). Clin Pharmacokinet. 2026 Feb;65(2):217-228. doi: 10.1007/s40262-025-01588-z. Epub 2025 Nov 18.
- Derived from this study: PubMed 38878207Mc Laughlin AM, Hess D, Michelet R, Colombo I, Haefliger S, Bastian S, Rabaglio M, Schwitter M, Fischer S, Eckhardt K, Hayoz S, Kopp C, Klose M, Sessa C, Stathis A, Halbherr S, Huisinga W, Joerger M, Kloft C. Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial. Cancer Chemother Pharmacol. 2024 Sep;94(3):349-360. doi: 10.1007/s00280-024-04679-z. Epub 2024 Jun 15.
- Derived from this study: PubMed 38377773Colombo I, Koster KL, Holer L, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Eckhardt K, Hayoz S, Mc Laughlin AM, Kloft C, Klose M, Halbherr S, Baumgartner C, Sessa C, Stathis A, Hess D, Joerger M. TLD-1, a novel liposomal doxorubicin, in patients with advanced solid tumors: Dose escalation and expansion part of a multicenter open-label phase I trial (SAKK 65/16). Eur J Cancer. 2024 Apr;201:113588. doi: 10.1016/j.ejca.2024.113588. Epub 2024 Feb 2.
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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.
Dagmar Hess, MD study chair
Cantonal Hospital of St. Gallen
Anastasios Stathis, MD study director
IOSI, Ospedale San Giovanni
Markus Jörger, Prof study director
Cantonal Hospital of St. Gallen
5 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 TLD-1 and Caelyx in people with Advanced Solid Tumors, run by Swiss Cancer Institute at 5 sites in Switzerland.
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 0 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 2 Dec 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 Switzerland. 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 was stopped early (reason given: The premature termination is based on the unexpectedly low patient accrual to the clinical trial and the strategic considerations in the development of the TLD-1 after having included 13 out of 14 patients in the comparative PK part.). 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?
Dose-limiting toxicity (DLT) (time frame: at 3 weeks). The study lists 7 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 NCT03387917, which also lists 3 linked publications.
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 2 Dec 2024.