Solid TumorPhase 1NCT03712423
PET Study With [89Zr]-Df-CriPec® Docetaxel
A Phase 1 study testing Cripec Docetaxel in people with Solid Tumor, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
A clinical phase I, open-label PET study with [89Zr]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of [89Zr]-Df-CriPec® docetaxel. 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?
- Cripec Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2018to 8 May 2020
- 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
- To be eligible to participate in this study, candidates must meet the following eligibility criteria:
- 1. Age ≥ 18 years 2 A pathologically confirmed diagnosis of advanced, recurrent and progressive cancer that is refractory to standard therapy or for which no standard therapy exist and where treatment with a taxane is an appropriate treatment option 3. Measurable or evaluable disease according to RECIST criteria v.1.1 Patient must have at least one measurable lesion with a short axis diameter of ≥ 2 cm.
- 4. Performance status (WHO scale/ ECOG) ≤ 1 (appendix 2) 5. Estimated life expectancy of at least 12 weeks 6. Toxicities incurred as a result of previous anti-cancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 2 (as defined by CTCAE version 4.0) 7. ANC ≥ 1.5 x10E9/L; platelets ≥ 100 x 10E9/L; Haemoglobin ≥ 6.0 mmol/L (≥ 9.6 g/dL) 8. Creatinine ≤ 1.5 x upper limit of normal (ULN); or creatinine clearance ≥ 60 mL/ min (Cockcroft-Gault) 9 Serum bilirubin ≤1.5 x ULN, alkaline phosphatase, ASAT and ALAT ≤ 2.5 x ULN, unless related to liver metastases, in which case ≤ 5x ULN is allowed 10 Written informed consent according to local guidelines
Who cannot join
- Candidates will be excluded from study entry if any of the following exclusion criteria are met:
- Less than 4 weeks since the last treatment with other anti-cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc.), less than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C prior to first study treatment.
- A history of skin toxicity as a result of prior treatment with taxanes
- If excessive sequestering of [ 89 Zr] CriPec®docetaxel in healthy liver is observed in the first 3 patients, patients with only liver lesion will not be eligible.
- Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
- Active or symptomatic brain metastases. Patients must be on a stable or deceasing dose of corticosteroids and/ or have no requirement for anticonvulsants for 5 days prior to Cycle 1 Day 1.
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- Current malignancies at other sites, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
- Major surgical procedure (including open biopsy, excluding central line IV and port-a- cath) within 27 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment
- Uncontrolled hypertension (systolic >150 mmHg and/ or diastolic > 100 mmHg)
- Grade ≥ 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 4.03)
- Known hypersensitivity to any of the study drugs or excipients or taxanes
- Any active skin condition associated with impaired skin integrity exposing the patient at risk to develop skin toxicity 12 Clinically significant (i.e. active) cardiovascular disease defined as:
- Stroke within ≤ 6 months prior to first study treatment;
- Transient Ischemic Attack (TIA) within ≤ 6 months prior to first study treatment ;
- Myocardial infarction within ≤ 6 months prior to first study treatment;
- Unstable angina;
- New Yotk Heart Association (NYHA) Grade II or greater Congestive Heart Failure (CHF);
- Serious cardiac arrhythmia requiring medication;
- Clinically relevant pathologic findings in electrocardiogram (ECG)
- Left ventricle Ejection Fraction (LVEF) by MUGA or ECHO < 50% 13 Patients who are pregnant or breastfeeding 14 Absence of effective means of contraception as of Run-in Day 1 in female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) ore in male patients who are not surgically sterile and who have female partners if childbearing potential 15 Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, drug or alcohol abuse, physical examination or laboratory finding) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment- related complications
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081 HV
About this study
Official title: A Clinical Phase I, Open-label, PET Study With [89Zr]-Df-CriPec® Docetaxel in Patients With Solid Tumours to Assess Biodistribution and Tumour Accumulation of [89Zr]-Df-CriPec® Docetaxel
A clinical phase I, open-label PET study with [89Zr]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of [89Zr]-Df-CriPec® docetaxel.
Read the detailed description
After patient inclusion an fludeoxyglucose-18 ([18F]-FDG) PET scan will be performed to delineate viable tumour lesions. On day 1, patients will receive a low dose of [89Zr]-Df-CriPec® docetaxel (corresponding to approximately 0.1-1 mg docetaxel) followed by maximally 3 [89Zr] PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 h - 9 days after administration) to evaluate biodistribution and tumour uptake. Two weeks later, the patients will receive unlabelled CriPec® docetaxel up to the Recommended Phase II Dose (RP2D) given every 3 weeks (Q3W) that will be determined in the phase I NAPOLY trial (CT-CL01), immediately followed by a second low dose of [89Zr]-Df-CriPec® docetaxel and maximally 3 [89Zr]PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 hrs - 9 days after administration) to evaluate biodistribution and tumour uptake with therapeutic dosage.
- Conditions
- Solid Tumor
- Being tested
- Cripec Docetaxel
- Keywords
- Nanoparticles, Positron-Emission Tomography, Docetaxel, Neoplasms, Quantification
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cripec DocetaxelDrug
Also called 89 Zirconium Cripec Docetaxel PET
89 Zirconium Cripec Docetaxel PET
| Study group | Role | What they receive |
|---|---|---|
| Patients [89Zr]-Df-CriPec® docetaxel | Experimental | Day 1 of the Run-in a low dose of [89Zr -Df-CriPec® docetaxel (corresponding to 0.1- 2 mg docetaxel). On Cycle 1 Day 1, the patients will receive unlabelled CriPec® docetaxel of a variable dose up to 60mg/m2 followed < 2 h by a second low dose of [89Zr]-Df-CriPec® docetaxel. On day 1 of each subsequent cycle, patients will only receive unlabelled CriPec® docetaxel . The dose will be the same as was given on Cycle 1 Day 1. For the following patients the dose of unlabelled CriPec® docetaxel combined with the low dose of [89Zr]-Df- CriPec® docetaxel will be variable but never exceed the highest dose of unlabelled CriPec® docetaxel that was determined to be safe in the phase I NAPOLY trial (CT-CL01). Receives: Drug: Cripec Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection (visual) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm)
Visual detection (absent/present) of tumor uptake
Measured: 14 days
Detection (quantitative) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm)
Measured by SUVpeak values of visual positive lesions
Measured: 14 days
Secondary outcomes (4)
Dosimetry of [89Zr]-Df-CriPec® docetaxel
Based on 89Zr PK activity concentration (Bq/ml) and biodistribution [89Zr]-Df-CriPec® docetaxel scans
Measured: 14 days
Optimal time point for PET imaging after [89Zr]-Df-CriPec® docetaxel administration
As assesed by a multidisciplinairy team
Measured: 14 days
Linearity between [89Zr]-Df-CriPec® docetaxel and total docetaxel
Assessment of 89Zr PK (Bq/ml) and total docetaxel (ng/ml)
Measured: 14 days
Biodistribution of low dose dose [89Zr]-Df-CriPec® docetaxel before and after administration of therapeutic dose of CriPec® docetaxel (quantified with %ID [89Zr] CriPec® docetaxel)
Measured by defining volumes of interest (VOI) of various organs on PET scan and calculating %ID/kg
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Apr 2018
- Primary completion25 Mar 2020
- Study completion8 May 2020
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.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I, open-label, single centre immune-PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Cristal Therapeutics
- Responsible party
- Principal investigator, C. Menke- van der Houven van Oordt, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712423
- Sponsor's protocol ID
- 2017-003664-12
- Other IDs
- 2017
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Phase I, Open-label, PET Study With [89Zr]-Df-CriPec® Docetaxel in Patients With Solid Tumours to Assess Biodistribution and Tumour Accumulation of [89Zr]-Df-CriPec® Docetaxel
- ClinicalTrials.gov ID
- NCT03712423
- Acronym / sponsor ID
- 2017-003664-12
- Conditions
- Solid Tumor
- Keywords
- Nanoparticles, Positron-Emission Tomography, Docetaxel, Neoplasms, Quantification
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Cristal Therapeutics
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 19 Oct 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.
A clinical phase I, open-label PET study with [89Zr]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of [89Zr]-Df-CriPec® docetaxel.
Detailed description
After patient inclusion an fludeoxyglucose-18 ([18F]-FDG) PET scan will be performed to delineate viable tumour lesions. On day 1, patients will receive a low dose of [89Zr]-Df-CriPec® docetaxel (corresponding to approximately 0.1-1 mg docetaxel) followed by maximally 3 [89Zr] PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 h - 9 days after administration) to evaluate biodistribution and tumour uptake. Two weeks later, the patients will receive unlabelled CriPec® docetaxel up to the Recommended Phase II Dose (RP2D) given every 3 weeks (Q3W) that will be determined in the phase I NAPOLY trial (CT-CL01), immediately followed by a second low dose of [89Zr]-Df-CriPec® docetaxel and maximally 3 [89Zr]PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 hrs - 9 days after administration) to evaluate biodistribution and tumour uptake with therapeutic dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, open-label, single centre immune-PET study with [89Zr]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of [89Zr]-Df-CriPec® docetaxel
| Arm | Type | Receives |
|---|---|---|
| Patients [89Zr]-Df-CriPec® docetaxel | Experimental | Drug: Cripec DocetaxelDay 1 of the Run-in a low dose of [89Zr -Df-CriPec® docetaxel (corresponding to 0.1- 2 mg docetaxel). On Cycle 1 Day 1, the patients will receive unlabelled CriPec® docetaxel of a variable dose up to 60mg/m2 followed < 2 h by a second low dose of [89Zr]-Df-CriPec® docetaxel. On day 1 of each subsequent cycle, patients will only receive unlabelled CriPec® docetaxel . The dose will be the same as was given on Cycle 1 Day 1. For the following patients the dose of unlabelled CriPec® docetaxel combined with the low dose of [89Zr]-Df- CriPec® docetaxel will be variable but never exceed the highest dose of unlabelled CriPec® docetaxel that was determined to be safe in the phase I NAPOLY trial (CT-CL01). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be eligible to participate in this study, candidates must meet the following eligibility criteria:
- 1. Age ≥ 18 years 2 A pathologically confirmed diagnosis of advanced, recurrent and progressive cancer that is refractory to standard therapy or for which no standard therapy exist and where treatment with a taxane is an appropriate treatment option 3. Measurable or evaluable disease according to RECIST criteria v.1.1 Patient must have at least one measurable lesion with a short axis diameter of ≥ 2 cm.
- 4. Performance status (WHO scale/ ECOG) ≤ 1 (appendix 2) 5. Estimated life expectancy of at least 12 weeks 6. Toxicities incurred as a result of previous anti-cancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 2 (as defined by CTCAE version 4.0) 7. ANC ≥ 1.5 x10E9/L; platelets ≥ 100 x 10E9/L; Haemoglobin ≥ 6.0 mmol/L (≥ 9.6 g/dL) 8. Creatinine ≤ 1.5 x upper limit of normal (ULN); or creatinine clearance ≥ 60 mL/ min (Cockcroft-Gault) 9 Serum bilirubin ≤1.5 x ULN, alkaline phosphatase, ASAT and ALAT ≤ 2.5 x ULN, unless related to liver metastases, in which case ≤ 5x ULN is allowed 10 Written informed consent according to local guidelines
Key exclusion criteria (20 listed)
- Candidates will be excluded from study entry if any of the following exclusion criteria are met:
- Less than 4 weeks since the last treatment with other anti-cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc.), less than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C prior to first study treatment.
- A history of skin toxicity as a result of prior treatment with taxanes
- If excessive sequestering of [ 89 Zr] CriPec®docetaxel in healthy liver is observed in the first 3 patients, patients with only liver lesion will not be eligible.
- Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
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 |
|---|---|---|
| Cripec DocetaxelAlso: 89 Zirconium Cripec Docetaxel PET89 Zirconium Cripec Docetaxel PET | Drug | Patients [89Zr]-Df-CriPec® docetaxel |
Primary outcome
Detection (visual) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm)
Time frame: 14 days
Visual detection (absent/present) of tumor uptake
Detection (quantitative) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm)
Time frame: 14 days
Measured by SUVpeak values of visual positive lesions
4 secondary outcomes
Dosimetry of [89Zr]-Df-CriPec® docetaxel
Time frame: 14 days
Optimal time point for PET imaging after [89Zr]-Df-CriPec® docetaxel administration
Time frame: 14 days
Linearity between [89Zr]-Df-CriPec® docetaxel and total docetaxel
Time frame: 14 days
Biodistribution of low dose dose [89Zr]-Df-CriPec® docetaxel before and after administration of therapeutic dose of CriPec® docetaxel (quantified with %ID [89Zr] CriPec® docetaxel)
Time frame: 14 days
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 8 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cripec Docetaxel in people with Solid Tumor, run by Amsterdam UMC, location VUmc at 1 site 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 3 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Detection (visual) of [89Zr]-Df-CriPec® docetaxel in tumour lesions (the short axis diameter of a visually assessable and quantifiable lesion must be ≥ 2 cm) (time frame: 14 days). 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 8 Oct 2020.