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AzTrials

CancerPhase 1NAPOLYNCT02442531

A Study of CriPec® Docetaxel Given to Patients With Solid Tumours

A Phase 1 study testing CriPec® docetaxel in people with Cancer and Metastatic Cancer, run by Cristal Therapeutics at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this Phase1 clinical research study is to find the highest safe dose of CriPec® docetaxel that can be given in the treatment of patients with solid tumours. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Metastatic Cancer, Solid Tumors
What is being tested?
CriPec® docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesin 2 countries
Study dates
Aug 2015to Jul 2018
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

  • At least 18 years old
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Estimated life expectancy of at least 12 weeks
  • Ability and willingness to give written informed consent and to comply with the requirements of the study
  • For Part 1:
  • Patients with pathologically confirmed diagnosis of advanced, recurrent and progressive solid tumours that are refractory to standard therapy or for whom no standard therapy exists and with measurable or evaluable disease according to RECIST 1.1.
  • For Part 2:
  • Patients with pathologically confirmed diagnosis of advanced, recurrent and progressive cancer with measurable disease according to RECIST 1.1 of a histological type that are refractory to standard therapy or for whom no standard therapy exists and where treatment with a taxane is an appropriate treatment option.

Who cannot join

  • Less than 4 weeks since the last treatment of chemotherapy, biological therapy, immunotherapy or systemic radiotherapy (except palliative radiation delivered to <20% of bone marrow), and less than 6 weeks for nitrosoureas and mitomycin C prior to Cycle 1 Day 1.
  • Current or recent (within 4 weeks prior to Cycle 1 Day 1) treatment with another Investigational Product or participation in another investigational interventional study.
  • Symptomatic brain metastases.
  • Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) that have not resolved to ≤ grade 2 (as defined by CTCAE version 4.03).
  • Inadequate bone marrow function at screening as evidenced by any of the following:
  • Absolute Neutrophil Count (ANC) < 1.5 x 109/L.
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  • Platelet count < 100 x 109/L.
  • Haemoglobin < 6.0 mmol/L (< 9.6 g/dL). The patient should not have received a transfusion or growth factors for these abnormalities in the 7 days prior to Cycle 1 Day 1.
  • Serum (total) bilirubin > 1.5 x the Upper Limit of Normal (ULN) for the institution if no liver metastases (> 2 x ULN in patients with liver metastases).
  • AST or ALT > 2.5 x ULN if no liver metastases (> 5x ULN in patients with liver metastases).
  • Alkaline phosphatase levels > 2.5 x ULN if no liver metastases (> 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases).
  • Increased plasma prothrombin time or International Normalized Ratio (INR), consequence of reduced hepatic production of Vitamin K.
  • Hepatitis B surface antigen or hepatitis C positivity with abnormal liver function tests.
  • Medical history of:
  • Nonalcoholic steatohepatitis (NASH).
  • History of human immunodeficiency virus (HIV) antibody positive or use of antiretroviral therapy.
  • Alcoholic and autoimmune hepatitis.
  • Ischemic hepatitis, Cardiovascular dysfunction or impaired liver oxygenation, including hypotension or right heart failure.
  • Serum creatinine > 1.5 x ULN.
  • Estimated Glomerular Filtration Rate of < 50 mL/min/1.73m2 calculated by Modification of Diet in Renal Disease (MDRD) formula or creatinine clearance of < 50 mL/min calculated by Cockcroft-Gault.
  • Stroke within 6 months prior to Cycle 1 Day 1.
  • Transient Ischemic Attack (TIA) within 6 months prior to Cycle 1 Day 1.
  • Myocardial infarction within 6 months prior to Cycle 1 Day 1.
  • Unstable angina.
  • New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure at screening.
  • Serious cardiac arrhythmia requiring medication.
  • Patients who are pregnant or breastfeeding.
  • Absence of effective means of contraception in female patients of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) or in male patients who are not surgically sterile and who have female partners of childbearing potential.
  • Major surgical procedure (including open biopsy and excluding central line intravenous catheter) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
  • Grade ≥2 motor or sensory neuropathy symptoms (as defined by CTCAE version 4.03).
  • Known hypersensitivity to any of the Investigational Product's excipients or taxanes.
  • History of drug or alcohol abuse in the opinion of the investigator within 3 years before screening.
  • Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk for treatment-related complications.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Netherlands3 sites

  • VUMC Amsterdam

    Amsterdam

  • UMC Groningen

    Groningen

  • Erasmus Medical Center

    Rotterdam

Other trials in Netherlands

Belgium1 site

  • University Hospital Leuven

    Leuven

Other trials in Belgium

About this study

Official title: A Phase I Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of CriPec® Docetaxel in Patients With Solid Tumours

The goal of this Phase1 clinical research study is to find the highest safe dose of CriPec® docetaxel that can be given in the treatment of patients with solid tumours.

Read the detailed description

The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of CriPec® docetaxel and to identify the Maximum Tolerated Dose (MTD).

Being tested
CriPec® docetaxel
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CriPec® docetaxelDrug

    Also called Docetaxel containing nanoparticles

    -3 weekly IV dose. Dose escalation; start dose 15 mg/m2. Number of cycles: 6 or until progression or unacceptable toxicity develops

Study groups in NCT02442531
Study groupRoleWhat they receive
CriPec® docetaxelExperimentalDocetaxel containing nanoparticle
Receives: Drug: CriPec® docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Incidence of grade 3 or 4 adverse events (AEs) as a measure of safety and tolerability.

    Part 1: Incidence of grade 3 or 4 adverse events (AEs) will be determined after escalating doses of CriPec® docetaxel once every three weeks.

    Measured: 9 months

  2. Part 1: Incidence of clinical laboratory abnormalities as a measure of safety and tolerability.

    Part 1: Incidence of laboratory abnormalities will be determined after escalating doses of CriPec® docetaxel once every three weeks.

    Measured: 9 months

  3. Part 1: Incidence of electrocardiogram (ECG) abnormalities as a measure of safety and tolerability.

    Part 1: Incidence of electrocardiogram (ECG) abnormalities will be determined after escalating doses of CriPec® docetaxel once every three weeks.

    Measured: 9 months

  4. Part 2: Incidence of grade 3 or 4 adverse events (AEs) at the Maximum Tolerated Dose (MTD) of CriPec® docetaxel as defined in Part 1.

    Part 2: Incidence of grade 3 or 4 adverse events (AEs) at the Maximum Tolerated Dose will be determined after CriPec® docetaxel dosing once every three weeks.

    Measured: 9 months

  5. Part 2: Incidence of clinical laboratory abnormalities at the Maximum Tolerated Dose (MTD) of CriPec® docetaxel as defined in Part 1

    Part 2: Incidence of clinical laboratory abnormalities at the Maximum Tolerated Dose will be determined after CriPec® docetaxel dosing once every three weeks.

    Measured: 9 months

  6. Part 2: Incidence of electrocardiogram (ECG) abnormalities at the Maximum Tolerated Dose (MTD) of CriPec® docetaxel as defined in Part 1

    Part 2: Incidence of electrocardiogram (ECG) abnormalities at the Maximum Tolerated Dose will be determined after CriPec® docetaxel dosing once every three weeks.

    Measured: 9 months

  7. Part 1 and 2: Pharmacokinetic profile of CriPec® docetaxel following IV infusion

    Pharmacokinetic parameters such as time to peak concentration (Tmax), peak concentration (Cmax), volume of distribution (Vd), half life (t1/2), total body clearance (CL) and area under the concentration-time curve (AUC) will be determined using plasma concentration data.

    Measured: First two cycles of CriPec® docetaxel (each cycle is 3 weeks)

Secondary outcomes (2)

  1. Early signs of anti-tumor efficacy (overall response rate [ORR]) of CriPec® docetaxel

    Measured: 18 months in total for part 1 and 2

  2. Early signs of anti-tumor efficacy (duration of response) of CriPec® docetaxel

    Measured: 18 months in total for part 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02442531
Sponsor's protocol ID
CT-CL01
Acronym
NAPOLY
Status last verified
Jul 2018
First submitted
1 May 2015
Last updated
24 Sep 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CriPec® docetaxel in people with Cancer and Metastatic Cancer, run by Cristal Therapeutics at 4 sites in 2 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 8 inclusion and 33 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 24 Sep 2018. 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 Netherlands, Belgium. 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?

Part 1: Incidence of grade 3 or 4 adverse events (AEs) as a measure of safety and tolerability. (time frame: 9 months). 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 NCT02442531.

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 24 Sep 2018.

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