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Trial record 68 of 119 for:    ZIRCONIUM

PET Study With [89Zr]-Df-CriPec® Docetaxel

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ClinicalTrials.gov Identifier: NCT03712423
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Cristal Therapeutics
Information provided by (Responsible Party):
C. Menke- van der Houven van Oordt, VU University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Cripec Docetaxel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients [89Zr]-Df-CriPec® docetaxel
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).
Drug: Cripec Docetaxel
89 Zirconium Cripec Docetaxel PET
Other Name: 89 Zirconium Cripec Docetaxel PET




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Dosimetry of [89Zr]-Df-CriPec® docetaxel [ Time Frame: 14 days ]
    Based on 89Zr PK activity concentration (Bq/ml) and biodistribution [89Zr]-Df-CriPec® docetaxel scans

  2. Optimal time point for PET imaging after [89Zr]-Df-CriPec® docetaxel administration [ Time Frame: 14 days ]
    As assesed by a multidisciplinairy team

  3. Linearity between [89Zr]-Df-CriPec® docetaxel and total docetaxel [ Time Frame: 14 days ]
    Assessment of 89Zr PK (Bq/ml) and total docetaxel (ng/ml)

  4. 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 ]
    Measured by defining volumes of interest (VOI) of various organs on PET scan and calculating %ID/kg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria are met:

  1. 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.
  2. A history of skin toxicity as a result of prior treatment with taxanes
  3. 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.
  4. Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
  5. 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.
  6. 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
  7. 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
  8. Uncontrolled hypertension (systolic >150 mmHg and/ or diastolic > 100 mmHg)
  9. Grade ≥ 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 4.03)
  10. Known hypersensitivity to any of the study drugs or excipients or taxanes
  11. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712423


Contacts
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Contact: Iris Miedema, MD +31 (0)20-4444321 trialoffice@vumc.nl

Locations
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Netherlands
VU University Medical Center Recruiting
Amsterdam, Noord- Holland, Netherlands, 1081 HV
Contact: Willemien C Menke-Van der Houven van Oordt, Dr    +31-20-4444321    trialoffice@vumc.nl   
Contact: Iris Miedema, MD    +31-20-4444321    trialoffice@vumc.nl   
Sponsors and Collaborators
VU University Medical Center
Cristal Therapeutics

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Responsible Party: C. Menke- van der Houven van Oordt, Principal Investigator, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03712423     History of Changes
Other Study ID Numbers: 2017-003664-12
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C. Menke- van der Houven van Oordt, VU University Medical Center:
Nanoparticles
Positron-Emission Tomography
Docetaxel
Neoplasms
Quantification
Additional relevant MeSH terms:
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Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action