An open-label cross-over proof of concept study to investigate the intratumoral pharmacokinetics of CriPec® docetaxel versus Taxotere® (the CRITAX study)

An open-label cross-over proof of concept study to investigate the intratumoral pharmacokinetics of CriPec® docetaxel versus Taxotere® (the CRITAX study) - The CRITAX study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47152

Enrollment

Registered

2016-05-12

Start date

2017-04-05

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer malignancy

Interventions

Subjects will be randomized in a 1:1 ratio to receive CriPec® docetaxel in cycle 1 and Taxotere® in cycle 2 (Arm A) or Taxotere® in cycle 1 and CriPec® docetaxel in cycle 2 (Arm B). CriPec® docetaxe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age * 18;Patients with advanced, unresectable and/or refractory solid tumors with no standard therapy options who could benefit from treatment with taxane containing chemotherapy;Signed informed consent;WHO Performance Status 0 or 1;Adequate organ function as defined by:;* Total bilirubine > 1.5 x ULN if no liver metastases (> 2 x ULN in patients with liver metastases). Except in case of documented Gilbert*s disease ;* AST or ALT > 2.5 x ULN if no liver metastases (> 5x ULN in patients with liver metastases);* Creatinine > 1.5 x ULN;Estimated life expectancy of at least 12 weeks;Willing to undergo repeated tumor and skin biopsies

Exclusion criteria

Exclusion criteria: Pregnant or lactating patients;Less than 4 weeks (prior to Cycle 1 Day 1) treatment with another Investigational Product or participation in another investigational interventional study.;Less than 4 weeks since the last anti-cancer therapy prior to Cycle 1 Day 1;Toxicities incurred as a result of previous anti-cancer therapy that have not resolved to * grade 2 except skin toxicity, this should be grade 0 at the base line;Known hypersensitivity to any of the Investigational Product*s excipients or taxanes;Symptomatic brain metastasis ;Patients unable to undergo study procedures

Design outcomes

Primary

Measure	Time frame
To show a 25% difference in concentration of docetaxel in tumor tissue after administration of CriPec® docetaxel compared to Taxotere®.	—

Secondary

Measure	Time frame
Systemic pharmacokinetics and adverse events: 1. Plasma levels of total and free docetaxel up to 24 hours after dosing and at the time of biopsy; Cmax, Tmax, AUClast, AUCinf, Thalf, Cl, Vss in relation to body weight (kg) where applicable. 3. The incidence of Grade 3 or 4 adverse events during cycle 1 and 2 according to CTCAE, version 4.03. Docetaxel PK and pathological changes in the skin after treatmet with CriPec® docetaxel and Taxotere®.	—

Measure

Time frame

Systemic pharmacokinetics and adverse events: 1. Plasma levels of total and free docetaxel up to 24 hours after dosing and at the time of biopsy; Cmax, Tmax, AUClast, AUCinf, Thalf, Cl, Vss in relation to body weight (kg) where applicable. 3. The incidence of Grade 3 or 4 adverse events during cycle 1 and 2 according to CTCAE, version 4.03. Docetaxel PK and pathological changes in the skin after treatmet with CriPec® docetaxel and Taxotere®.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)