A Phase I Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of CriPec® docetaxel in Patients with Solid Tumours.

Recruiting

• Conditions: solid tumours / abnormal cell division in a particular organ; 10027655

• Registration Number: NL-OMON44828
• Lead Sponsor: Cristal Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

1. Age >= 18 years at signing of Informed Consent Form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
3. Estimated life expectancy of at least 12 weeks.
4. Ability and willingness to give written informed consent and to comply with the requirements of the study.
In addition to the above listed eligibility criteria, the following criteria are applicable:
Part 1
5. 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.
Part 2 and part 3
6. Patients with pathologically confirmed diagnosis of advanced, recurrent and progressive cancer with measurable disease according to RECIST 1.1 that are refractory to standard therapy or for whom no standard therapy exists and where treatment with a taxane is an appropriate treatment option

Exclusion Criteria

A patient who meets ANY of the following criteria at screening and/or <=3 days of Cycle 1 Day 1 prior to Investigational Product administration (unless otherwise noted below) is not eligible for this study:
1. 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.
2. Current or recent (within 4 weeks prior to Cycle 1 Day 1) treatment with another Investigational Product or participation in another investigational interventional study.
3. Symptomatic brain metastases.
4. Toxicities incurred as a result of previous anti-cancer therapy (radiation therapy, chemotherapy, or surgery) that have not resolved to <= grade 2 (as defined by CTCAE version 4.03).
5. Abnormal lab results which could indicate inadequate bone marrow function, as evidenced by any of the following at screening and/or <= 3 days of Cycle 1 Day 1 prior to Investigational Product :
* Absolute Neutrophil Count (ANC) < 1.5 x 109/L.
* Platelet count < 100 x 109/L.
* Haemoglobin < 6.0 mmol/L (< 9.6 g/dL).
The patient may not have received a transfusion or growth factors for these abnormalities in the 7 days prior to Cycle 1 Day 1.
Inadequate liver function as evidenced by any of the following at screening and/or <= 3 days of Cycle 1 Day 1 prior to Investigational Product Administration:
6. 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).
7. AST or ALT > 2.5 x ULN if no liver metastases (> 5x ULN in patients with liver metastases).
8. 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).
9. International Normalized Ratio (INR) >1.3, consequence of reduced hepatic production of Vitamin K.
10. Hepatitis B surface antigen or hepatitis C positivity in combination with abnormal liver function tests as determined by the Investigator.
11. Medical history of:
* Non-alcoholic steatohepatitis (NASH).
* History of human immunodeficiency virus (HIV) antibody positive or use of antiretroviral therapy.
* Alcoholic and autoimmune hepatitis.
* Ischemic hepatitis, inadequate liver function due to cardiovascular dysfunction or impaired liver oxygenation (e.g. due to hypotension or right heart failure).
Inadequate renal function as evidenced by any of the following at screening and/or <= 3 days of Cycle 1 Day 1 prior to Investigational Product Administration:
12. Serum creatinine > 1.5 x ULN.
13. 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.
Clinically significant (i.e. active) cardiovascular disease as evidenced by any of the following at screening and/or Cycle 1 Day 1 (unless otherwise noted below):
14. Stroke within 6 months prior to Cycle 1 Day 1.
15. Transient Ischemic Attack (TIA) within 6 months prior to Cycle 1 Day 1.
16. Myocardial infarction within 6 months prior to Cycle 1 Day 1.
17. Unstable angina.
18. New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure at screening.
19. Serious cardi

Study & Design

• Study Type: Interventional
• Study Design: Not specified