Solid TumorPhase 1NCT04810208
Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours
A Phase 1 study testing Docetaxel in people with Solid Tumor, run by Lidds AB at 4 sites in 3 countries.
Trial summary
This is a multicentre, open-label, first in man, study of a novel NanoZolid®-docetaxel depot formulation (NZ-DTX Depot) given as an intra-tumoural injection in patients with advanced solid tumours. The study includes a dose escalation part and a dose expansion part. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 28 Feb 2019to 7 Oct 2021
- 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
- Signed written informed consent granted before undertaking any study-specific procedures;
- Male or female patient ≥18 years of age on the day of consenting to the study;
- Histologically or cytologically confirmed diagnosis of solid cancer;
- At least 1 advanced solid, palpable, cutaneous or subcutaneous tumour lesion with following characteristics:
- a cutaneous lesion with of thickness ≥4 mm and diameter ≥25 mm at the longest axis, or
- a subcutaneous lesion of diameter ≥20 mm at the longest and the shortest axis;
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- Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0-2;
- Patient from one the following categories:
- Patient for whom no standard therapy exists, or standard therapy is contraindicated, or
- Patient who is scheduled for other anti-cancer treatment (e.g. radiotherapy, immunological treatment, surgery) which will start after completion of at least one treatment cycle of NZ-DTX, i.e after the end-of-study (EOS) visit.
Who cannot join
- Known hypersensitivity to any of the excipients in the NZ-DTX Depot formulation (docetaxel, calcium sulphate, sodium carboxymethylcellulose);
- Life expectancy <3 months;
- Bleeding deficiencies or ongoing anticoagulant therapy that would put the patient at increased risk of clinically significant bleeding, in the judgement of the Investigator. If the patient has an international normalised ratio (INR) below 1.2 the Investigator may judge if interruption of anticoagulant therapy is warranted;
- Any of the following abnormal laboratory values at screening;
- Bone marrow function:
- Absolute neutrophil count (ANC) <1.5 x 109/l;
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- Platelet count <100 x 109/l;
- Haemoglobin <9.0 mg/dl.
- Coagulation:
- International Normalized Ratio (INR) >1.2.
- Hepatic, renal, and biochemistry parameters:
- Aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 x upper limit of normal (ULN) (>5 x ULN if liver metastases present)*;
- Alkaline phosphatase (ALP) >2.5 x ULN;
- Total bilirubin >1.5 x ULN;
- Estimated glomerular filtration rate (eGFR) <40 ml/min/1.73 m² using the Modified Cockcroft \& Gault formula.
- For patients with liver impairment who have serum transaminase levels (ALT and/or AST) greater than 1.5 times x ULN - the doses will be restricted to max. 75mg/m2. In the event this is not possible the patient will not be included.
- Severe fluid retention, e.g. pulmonary oedema, pleural effusion, pericardial effusion or ascites;
- Clinically significant heart disease (i.e. heart failure or myocardial infarction within 6 months of screening, instable angina pectoris);
- History of thromboembolic or cerebrovascular events within 6 months of screening;
- Major surgery within 2 weeks of screening, or patient not recovered from major surgery;
- Known untreated or uncontrolled acute infection, including urinary tract infection, within 7 days of screening;
- Not recovered from Grade 2 or higher adverse events (AEs) due to previous treatments, excepting alopecia;
- Concurrent participation in another investigational study;
- Last investigational drug administration in a prior investigational study within 14 days of study treatment initiation or <5 times the half-life of the investigational drug, whichever is longer;
- Last administration of other anti-neoplastic drug within 14 days of study treatment initiation;
- Radiotherapy of lesion to be injected within 4 weeks of first treatment with NZ-DTX Depot, or irradiated lesion to be injected without signs of disease progression since irradiation;
- For men and women of childbearing potential: Unwillingness to follow contraception requirements;
- Female patients with planned or current pregnancy and/or currently breastfeeding;
- Any other severe, acute or chronical medical or psychiatric condition or laboratory abnormality that, in the judgement of the Investigator, would make the patient inappropriate for study participation.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Lithuania2 sites
Lithuanian University of Health Sciences
Kaunas
National Cancer Institute
Vilnius
About this study
Official title: A Phase Ia/Ib, First-in-human, Open Label, Multicentre, Dose-escalation and Dose-expansion Study of a Novel NanoZolid®-Docetaxel Depot Formulation (NZ-DTX Depot) Given as an Intra-tumoural Injection in Patients With Advanced Solid Tumours
This is a multicentre, open-label, first in man, study of a novel NanoZolid®-docetaxel depot formulation (NZ-DTX Depot) given as an intra-tumoural injection in patients with advanced solid tumours. The study includes a dose escalation part and a dose expansion part.
- Conditions
- Solid Tumor
- Being tested
- Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel in NanoZolid formulation, for intratumoural injection
| Study group | Role | What they receive |
|---|---|---|
| NZ-DTX Depot | Experimental | Not described Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of NZ-DTX Depot given as an intra-tumoural injection in solid, palpable, cutaneous or subcutaneous tumour lesions.
The MTD will be determined by incidence of DLTs
Measured: 5 weeks
The recommended Phase 2 dose (RP2D) of NZ-DTX Depot given as an intra-tumoural injection in a solid, palpable cutaneous or subcutaneous tumour lesion.
The RP2D will be determined by frequency and severity of adverse events
Measured: 5 weeks
Secondary outcomes (3)
Frequency and severity of treatment-emergent adverse events [safety and tolerability] following an intratumoural injection of NZ-DTX Depot
Frequency and severity of treatment-emergent adverse events
Measured: 5 weeks
Plasma concentration of docetaxel, following an intratumoural injection of NZ-DTX Depot
Plasma concentration of docetaxel
Measured: 5 weeks
Anti-tumour effect following an intratumoural injection of NZ-DTX Depot
Tumour response by RECIST
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start28 Feb 2019
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lidds AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotta Gauffin, PhD, Study director, Lidds AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810208
- Sponsor's protocol ID
- NZ-DTX-001
- Status last verified
- Dec 2021
- First submitted
- 18 Mar 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, First-in-human, Open Label, Multicentre, Dose-escalation and Dose-expansion Study of a Novel NanoZolid®-Docetaxel Depot Formulation (NZ-DTX Depot) Given as an Intra-tumoural Injection in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT04810208
- Acronym / sponsor ID
- NZ-DTX-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lidds ABIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre, open-label, first in man, study of a novel NanoZolid®-docetaxel depot formulation (NZ-DTX Depot) given as an intra-tumoural injection in patients with advanced solid tumours. The study includes a dose escalation part and a dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NZ-DTX Depot | Experimental | Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent granted before undertaking any study-specific procedures;
- Male or female patient ≥18 years of age on the day of consenting to the study;
- Histologically or cytologically confirmed diagnosis of solid cancer;
- At least 1 advanced solid, palpable, cutaneous or subcutaneous tumour lesion with following characteristics:
- Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0-2;
Key exclusion criteria (29 listed)
- Known hypersensitivity to any of the excipients in the NZ-DTX Depot formulation (docetaxel, calcium sulphate, sodium carboxymethylcellulose);
- Life expectancy <3 months;
- Bleeding deficiencies or ongoing anticoagulant therapy that would put the patient at increased risk of clinically significant bleeding, in the judgement of the Investigator. If the patient has an international normalised ratio (INR) below 1.2 the Investigator may judge if interruption of anticoagulant therapy is warranted;
- Any of the following abnormal laboratory values at screening;
- Severe fluid retention, e.g. pulmonary oedema, pleural effusion, pericardial effusion or ascites;
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 |
|---|---|---|
| DocetaxelDocetaxel in NanoZolid formulation, for intratumoural injection | Drug | NZ-DTX Depot |
Primary outcome
Maximum tolerated dose (MTD) of NZ-DTX Depot given as an intra-tumoural injection in solid, palpable, cutaneous or subcutaneous tumour lesions.
Time frame: 5 weeks
The MTD will be determined by incidence of DLTs
The recommended Phase 2 dose (RP2D) of NZ-DTX Depot given as an intra-tumoural injection in a solid, palpable cutaneous or subcutaneous tumour lesion.
Time frame: 5 weeks
The RP2D will be determined by frequency and severity of adverse events
3 secondary outcomes
Frequency and severity of treatment-emergent adverse events [safety and tolerability] following an intratumoural injection of NZ-DTX Depot
Time frame: 5 weeks
Plasma concentration of docetaxel, following an intratumoural injection of NZ-DTX Depot
Time frame: 5 weeks
Anti-tumour effect following an intratumoural injection of NZ-DTX Depot
Time frame: 5 weeks
Results and safety
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
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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.
Charlotta Gauffin, PhD study director
Lidds AB
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel in people with Solid Tumor, run by Lidds AB at 4 sites in 3 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 10 inclusion and 29 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 30 Dec 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 Lithuania, Denmark, Sweden. 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: Strategic decision). 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?
Maximum tolerated dose (MTD) of NZ-DTX Depot given as an intra-tumoural injection in solid, palpable, cutaneous or subcutaneous tumour lesions. (time frame: 5 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?
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 30 Dec 2021.