solid tumours / abnormal cell division in a particular organ
Conditions
Interventions
Upon completion of Cycle 1 and in the absence of progressive disease (PD) or
unacceptable toxicity, patients in all parts of the study may receive
additional cycles of treatment, with ongoing safety
docetaxel
nanomedicines
solid tumours
Sponsors
Cristal Therapeutics
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria: A patient who meets ANY of the following criteria at screening and/or 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for Part 1 are: • The incidence of Grade 3 or 4 adverse events (AEs) defined as dose-limiting toxicities Dose Limiting Toxicities (DLTs). • PK parameters including: o Plasma levels of total and released docetaxel up to 1 week after 1st dose: Cmax, Tmax, AUClast, AUCinf, Thalf, lambda z, Cl and Vss in relation to body surface area (m2) where applicable. Cmax, Tmax, AUClast, AUCinf, Thalf, lambda z, Cl, and Vss will also be determined after the 2nd dose. o Comparison of the PK profile of total and released docetaxel in repeated dosing versus initial dosing. The primary endpoints for Part 2 are: • Safety and tolerability profile of CriPec docetaxel given every two weeks (Q2W) including the incidence of Dose Limiting Toxicities (DLTs) • PK parameters in Q2W dosing: plasma levels of total and released docetaxel after single and repeated dosing. The primary endpoints of Part 3 are: • Safety and tolerability profile of CriPec docetaxel given Q3W including the incidence of DLTs • Plasma levels of total and released docetaxel after single and repeated dosing of CriPec docetaxel given Q3W | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint for Part 1 is the response rate and duration of response per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The secondary endpoint for Part 2 is the response rate and duration of response per RECIST Version 1.1. The secondary endpoints for Part 3 are: • Response rate and duration of response per RECIST Version 1.1. • Level of total docetaxel in tumour tissue biopsies | — |
Countries
Belgium, Netherlands
Outcome results
None listed