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

NCT03712423 | Completed Phase 1 DMC

• 1 other identifier: 2017-003664-12
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Nanoparticles; Positron-Emission Tomography; Docetaxel; Neoplasms; Quantification

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 days

Secondary Outcomes (4)

• Dosimetry of [89Zr]-Df-CriPec® docetaxel

  14 days

• Optimal time point for PET imaging after [89Zr]-Df-CriPec® docetaxel administration

  14 days

• Linearity between [89Zr]-Df-CriPec® docetaxel and total docetaxel

  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)

  14 days

Study Arms (1)

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).

Drug: Cripec Docetaxel

Interventions

Cripec Docetaxel DRUG

89 Zirconium Cripec Docetaxel PET

Also known as: 89 Zirconium Cripec Docetaxel PET

Patients [89Zr]-Df-CriPec® docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, candidates must meet the following eligibility criteria:
• \. 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.
• \. 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

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Cristal Therapeutics: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 19, 2018
• Study Start: April 1, 2018
• Primary Completion: March 25, 2020
• Study Completion: May 8, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)